This is a single center, open-label, fixed sequence Phase 1, drug-drug interaction (DDI) study in healthy subjects.
Following a Screening period, eligible subjects will be enrolled sequentially to one of three cohorts to receive a single dose of probe substrate(s), followed by repeated titrated doses of ecopipam twice daily (BID) (with subjects in Cohort 3 also receiving a single dose of ecopipam and probe substrates on Day 4 prior to titration). After steady-state ecopipam dosing is reached, ecopipam will be co-administered with a single dose of probe substrate(s) (with continuation of ecopipam BID (every 12 h) dosing during the blood sampling period for the respective probe substrates), followed by an ecopipam tapering period and clinic discharge assessments.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
56
ecopipam HCl \~2mg/kg/day
dextromethorphan, caffeine, omeprazole, and midazolam
bupropion
ICON Early Phase Services
San Antonio, Texas, United States
Cmax of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
Cmax of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
Cmax of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
Cmax oral midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
Cmax of dabigatran in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
Cmax of dabigatran in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
Cmax of pitavastatin (and its pitavastatin lactone metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
dabigatran, pitavastatin, rosuvastatin, atorvastatin, midazolam
Cmax of pitavastatin (and its pitavastatin lactone metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
Cmax of rosuvastatin in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
Cmax of rosuvastatin in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
Cmax of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
Cmax of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUCinf of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUCinf of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUCinf of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUCinf of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUCinf of dabigatran in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUCinf of dabigatran in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUCinf of pitavastatin (and its pitavastatin lactone metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUCinf of pitavastatin (and its pitavastatin lactone metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUCinf of rosuvastatin in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUCinf of rosuvastatin in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUCinf of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUCinf of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUClast of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUClast of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUClast of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUClast of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUClast of dabigatran in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUClast of dabigatran in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUClast of pitavastatin (and its pitavastatin lactone metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUClast of pitavastatin (and its pitavastatin lactone metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUClast of rosuvastatin in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUClast of rosuvastatin in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUClast of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUClast of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUC0-24 of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUC0-24 of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUC0-24 of dabigatran in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUC0-24 of dabigatran in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUC0-24 of pitavastatin (and its pitavastatin lactone metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUC0-24 of pitavastatin (and its pitavastatin lactone metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUC0-24 of rosuvastatin in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUC0-24 of rosuvastatin in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUC0-24 of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUC0-24 of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
Cmax of bupropion (and its 4-hydroxybupropion metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
Cmax of bupropion (and its 4-hydroxybupropion metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
Cmax omeprazole (and its 5'-hydroxy omeprazole metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
Cmax omeprazole (and its 5'-hydroxy omeprazole metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUCinf of bupropion (and its 4-hydroxybupropion metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUCinf of bupropion (and its 4-hydroxybupropion metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUCinf of omeprazole (and its 5'-hydroxy omeprazole metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUCinf of omeprazole (and its 5'-hydroxy omeprazole metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUClast of bupropion (and its 4-hydroxybupropion metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUClast of bupropion (and its 4-hydroxybupropion metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUClast of omeprazole (and its 5'-hydroxy omeprazole metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
AUClast of omeprazole (and its 5'-hydroxy omeprazole metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
CL/F for dextromethorphan in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
CL/F for dextromethorphan in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
CL for IV midazolam in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
CL for IV midazolam in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
CL/F for oral midazolam in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
CL/F for oral midazolam in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
CL/F for dabigatran in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
CL/F for dabigatran in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
CL/F for pitavastatin in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
CL/F for pitavastatin in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
CL/F for rosuvastatin in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
CL/F for rosuvastatin in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
CL/F for atorvastatin in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
CL/F for atorvastatin in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
CL/F for bupropion in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
CL/F for bupropion in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
CL/F for caffeine in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
CL/F for caffeine in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
CL/F for omeprazole in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
CL/F for omeprazole in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
V/F for dextromethorphan in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
V/F for dextromethorphan in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
V for IV midazolam in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
V for IV midazolam in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
V/F for oral midazolam in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
V/F for oral midazolam in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
V/F for dabigatran in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
V/F for dabigatran in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
V/F for pitavastatin in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
V/F for pitavastatin in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
V/F for rosuvastatin in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
V/F for rosuvastatin in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
V/F for bupropion in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
V/F for bupropion in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
V/F for atorvastatin in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
V/F for atorvastatin in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
V/F for caffeine in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
V/F for caffeine in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
V/F for omeprazole in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
V/F for omeprazole in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 22
Total concentration of bilirubin in the presence of ecopipam
Bilirubin sampling will occur on Day 1 and Day 18
Time frame: Up to Day 18
Total concentration of bilirubin in the absence of ecopipam
Bilirubin sampling will occur on Day 1 and Day 18
Time frame: Up to Day 18
Unconjugated concentration of bilirubin in the presence of ecopipam
Bilirubin sampling will occur on Day 1 and Day 18
Time frame: Up to Day 18
Unconjugated concentration of bilirubin in the absence of ecopipam
Bilirubin sampling will occur on Day 1 and Day 18
Time frame: Up to Day 18
Conjugated concentration of bilirubin in the presence of ecopipam
Bilirubin sampling will occur on Day 1 and Day 18
Time frame: Up to Day 18
Conjugated concentration of bilirubin in the absence of ecopipam
Bilirubin sampling will occur on Day 1 and Day 18
Time frame: Up to Day 18
Average of the 6-hour plasma dextromethorphan: dextrorphan ratio in the presence of ecopipam
6 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 14
Average of the 8-hour plasma dextromethorphan: dextrorphan ratio in the presence of ecopipam
6 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 14
Average of the 12-hour plasma dextromethorphan: dextrorphan ratio in the presence of ecopipam
6 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 14
Average of the 6-hour plasma dextromethorphan: dextrorphan ratio in the absence of ecopipam
6 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 14
Average of the 8-hour plasma dextromethorphan: dextrorphan ratio in the absence of ecopipam
6 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 14
Average of the 12-hour plasma dextromethorphan: dextrorphan ratio in the absence of ecopipam
6 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 14
Average of the 6-hour plasma caffeine: paraxanthine metabolite ratio in the presence of ecopipam
6 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 14
Average of the 8-hour plasma caffeine: paraxanthine metabolite ratio in the presence of ecopipam
6 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 14
Average of the 12-hour plasma caffeine: paraxanthine metabolite ratio in the presence of ecopipam
6 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 14
Average of the 6-hour plasma caffeine: paraxanthine metabolite ratio in the absence of ecopipam
6 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 14
Average of the 8-hour plasma caffeine: paraxanthine metabolite ratio in the absence of ecopipam
6 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 14
Average of the 12-hour plasma caffeine: paraxanthine metabolite ratio in the absence of ecopipam
6 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Time frame: Up to Day 14
Safety and tolerability as demonstrated by the Modified Observer's Assessment of Alertness/Sedation (MOAA/S)
Score from 0-5 where 0 is no response and 5 is responds readily. MOAA/S measures will be recorded at the indicated timepoints
Time frame: Up to Day 63
Safety and tolerability as demonstrated by the Columbia Suicide Severity Rating Scale (C-SSRS)
Safety and tolerability measures will be recorded at the indicated timepoints
Time frame: Up to Day 63
Number of participants requiring concomitant medications
Participants will be continuously monitored for the use of concomitant medications
Time frame: Up to Day 63
AEs with relatedness associated with dextromethorphan
Subjects will be continually monitored for adverse events
Time frame: Up to Day 63
AEs with relatedness associated with IV midazolam
Subjects will be continually monitored for adverse events
Time frame: Up to Day 63
AEs with relatedness associated with oral midazolam
Subjects will be continually monitored for adverse events
Time frame: Up to Day 63
AEs with relatedness associated with dabigatran
Subjects will be continually monitored for adverse events
Time frame: Up to Day 63
AEs with relatedness associated with pitavastatin
Subjects will be continually monitored for adverse events
Time frame: Up to Day 63
AEs with relatedness associated with rosuvastatin
Subjects will be continually monitored for adverse events
Time frame: Up to Day 63
AEs with relatedness associated with atorvastatin
Subjects will be continually monitored for adverse events
Time frame: Up to Day 63
AEs with relatedness associated with bupropion
Subjects will be continually monitored for adverse events
Time frame: Up to Day 63
AEs with relatedness associated with caffeine
Subjects will be continually monitored for adverse events
Time frame: Up to Day 63
AEs with relatedness associated with omeprazole
Subjects will be continually monitored for adverse events
Time frame: Up to Day 63
AEs with relatedness associated with ecopipam
Subjects will be continually monitored for adverse events
Time frame: Up to Day 63
Absolute values of white blood cell (WBC), neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelets (1000/mm3)
Blood samples will be collected for the assessment of hematology parameters
Time frame: Up to Day 26
Absolute values of hematocrit (percent)
Blood samples will be collected for the assessment of hematology parameters
Time frame: Up to Day 26
Absolute values of hemoglobin (g/dL)
Blood samples will be collected for the assessment of hematology parameters
Time frame: Up to Day 26
Absolute values of Red blood cell (RBC) count (M/mm3)
Blood samples will be collected for the assessment of hematology parameters
Time frame: Up to Day 26
Absolute values of sodium, potassium, chloride (mmol/L)
Blood samples will be collected for the assessment of clinical chemistry parameters
Time frame: Up to Day 26
Absolute values of magnesium, urea, phosphorus, calcium, glucose, and total, conjugated and unconjugated bilirubin (mg/dL)
Blood samples will be collected for the assessment of clinical chemistry parameters
Time frame: Up to Day 26
Absolute values of albumin and total protein (g/dL)
Blood samples will be collected for the assessment of clinical chemistry parameters
Time frame: Up to Day 26
Absolute values of alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma glutamyl transferase (GGT), creatinine phosphokinase (CPK), and creatinine (U/L)
Blood samples will be collected for the assessment of clinical chemistry parameters
Time frame: Up to Day 26
Absolute values of urine specific gravity
Urine samples will be collected for the assessment of urine parameters
Time frame: Up to Day 26
Absolute values of urine pH
Urine samples will be collected for the assessment of urine parameters
Time frame: Up to Day 26
Absolute values of urine glucose
Urine samples will be collected for the assessment of urine parameters
Time frame: Up to Day 26
Absolute values of urine protein
Urine samples will be collected for the assessment of urine parameters
Time frame: Up to Day 26
Absolute values of urine blood
Urine samples will be collected for the assessment of urine parameters
Time frame: Up to Day 26
Absolute values of urine ketones
Urine samples will be collected for the assessment of urine parameters
Time frame: Up to Day 26
Absolute values of urine bilirubin and nitrite
Urine samples will be collected for the assessment of urine parameters
Time frame: Up to Day 26
Absolute values of urobilinogen (Eu/dL)
Urine samples will be collected for the assessment of urine parameters
Time frame: Up to Day 26
Absolute values of urine leukocytes by dipstick
Urine samples will be collected for the assessment of urine parameters
Time frame: Up to Day 26
Change from Day -1 to Day of Discharge white blood cell (WBC), neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelets (1000/mm3)
Blood samples will be collected for the assessment of hematology parameters
Time frame: Up to Day 26
Change from Day -1 to Day of Discharge in hematocrit (percent)
Blood samples will be collected for the assessment of hematology parameters
Time frame: Up to Day 26
Change from Day -1 to Day of Discharge in hemoglobin (g/dL)
Blood samples will be collected for the assessment of hematology parameters
Time frame: Up to Day 26
Change from Day -1 to Day of Discharge in Red blood cell (RBC) count (M/mm3)
Blood samples will be collected for the assessment of hematology parameters
Time frame: Up to Day 26
Change from Day -1 to Day of Discharge in sodium, potassium, chloride (mmol/L)
Blood samples will be collected for the assessment of clinical chemistry parameters
Time frame: Up to Day 26
Change from Day -1 to Day of Discharge in magnesium, urea, phosphorus, calcium, glucose, and total, conjugated and unconjugated bilirubin (mg/dL)
Blood samples will be collected for the assessment of clinical chemistry parameters
Time frame: Up to Day 26
Change from Day -1 to Day of Discharge in albumin and total protein (g/dL)
Blood samples will be collected for the assessment of clinical chemistry parameters
Time frame: Up to Day 26
Change from Day -1 to Day of Discharge in alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma glutamyl transferase (GGT), and creatinine phosphokinase (CPK), and creatinine (U/L)
Blood samples will be collected for the assessment of clinical chemistry parameters
Time frame: Up to Day 26
Change from Day -1 to Day of Discharge in urine specific gravity
Urine samples will be collected for the assessment of urine parameters
Time frame: Up to Day 26
Change from Day -1 to Day of Discharge in urine pH
Urine samples will be collected for the assessment of urine parameters
Time frame: Up to Day 26
Change from Day -1 to Day of Discharge in urine glucose
Urine samples will be collected for the assessment of urine parameters
Time frame: Up to Day 26
Change from Day -1 to Day of Discharge in urine protein
Urine samples will be collected for the assessment of urine parameters
Time frame: Up to Day 26
Change from Day -1 to Day of Discharge in urine blood
Urine samples will be collected for the assessment of urine parameters
Time frame: Up to Day 26
Change from Day -1 to Day of Discharge in urine ketones
Urine samples will be collected for the assessment of urine parameters
Time frame: Up to Day 26
Change from Day -1 to Day of Discharge in urine bilirubin and nitrite
Urine samples will be collected for the assessment of urine parameters
Time frame: Up to Day 26
Change from Day -1 to Day of Discharge in urobilinogen (Eu/dL)
Urine samples will be collected for the assessment of urine parameters
Time frame: Up to Day 26
Change from Day -1 to Day of Discharge in urine leukocytes by dipstick
Urine samples will be collected for the assessment of urine parameters
Time frame: Up to Day 26
Absolute values of electrocardiogram (ECG) parameters: PR, QRS, QT, and QT interval corrected for heart rate using Fridericia's formula (QTcF) (Milliseconds)
Twelve-lead ECGs will be obtained with the participant in a supine position after a rest of at least 5 minutes using an automated ECG machine. PR, QRS, QT, and QTcF intervals will be measured
Time frame: Up to Day 26
Change from pre-dose for the respective day in ECG parameters: PR, QRS, QT, and QTcF (Milliseconds)
Twelve-lead ECGs will be obtained with the participant in a supine position after a rest of at least 5 minutes using an automated ECG machine. PR, QRS, QT, and QTcF intervals will be measured
Time frame: Up to Day 26
Absolute values of oral temperature (degrees Celsius)
Temperature will be assessed as part of vital signs
Time frame: Up to Day 26
Change from pre-dose for the respective day in oral temperature (degrees Celsius)
Temperature will be assessed as part of vital signs
Time frame: Up to Day 26
Absolute values of heart rate (beats/minute)
Heart rate will be assessed as part of vital signs
Time frame: Up to Day 26
Change from pre-dose for the respective day in heart rate (beats/minute)
Heart rate will be assessed as part of vital signs
Time frame: Up to Day 26
Absolute values of respiratory rate (breaths/minute)
Respiratory rate will be assessed as part of vital signs
Time frame: Up to Day 26
Absolute values of systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHG)
Blood pressure will be assessed as part of vital signs
Time frame: Up to Day 26
Change from pre-dose for the respective day in SBP and DBP (mmHG)
Blood pressure will be assessed as part of vital signs
Time frame: Up to Day 26
Absolute values of mean corpuscular hemoglobin (MCH) (pg)
Blood samples will be collected for the assessment of hematology parameters
Time frame: Up to Day 26
Change from Day 1 to Day of Discharge of mean corpuscular hemoglobin (MCH) (pg)
Blood samples will be collected for the assessment of hematology parameters
Time frame: Up to Day 26
Absolute values of mean corpuscular volume (MCV) (fL)
Blood samples will be collected for the assessment of hematology parameters
Time frame: Up to Day 26
Change from Day 1 to Day of Discharge of mean corpuscular volume (MCV) (fL)
Blood samples will be collected for the assessment of hematology parameters
Time frame: Up to Day 26
Absolute values of mean corpuscular hemoglobin concentration (MCHC) (g/dL)
Blood samples will be collected for the assessment of hematology parameters
Time frame: Up to Day 26
Change from Day 1 to Day of Discharge of mean corpuscular hemoglobin concentration (MCHC) (g/dL)
Blood samples will be collected for the assessment of hematology parameters
Time frame: Up to Day 26