This trial will determine the Pharmacokinetics, safety and tolerability of single-dose Aripiprazole administered intramuscularly in adults with schizophrenia
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
36
Injection
Woodland International Research Group
Little Rock, Arkansas, United States
CNRI-San Diego
San Diego, California, United States
Community Clinical Research Inc.
Austin, Texas, United States
Incidence of Adverse Events (AEs) [safety and tolerability]
AEs will be monitored to assess safety and tolerability of drug
Time frame: Screening Days -30 to Day 182 post dose/Early Termination
Clinical Laboratory Tests [safety and tolerability]
Hematology, clinical chemistry \& urinalysis tests will be performed to assess the safety and tolerability of drug.
Time frame: Screening Days -30 to Day 182 post dose/Early Termination
Electrocardiograms (ECGs) [Safety and tolerability]
Heart rate, RR, PR, WRS and WT intervals will be monitored to assess the safety and tolerability of the drug.
Time frame: Screening Days -30 to Day 182 post dose/Early Termination
Vital Signs [safety and tolerability]
Systolic/diastolic blood pressure, heart rate and body temperature will be monitored to assess the safety and tolerability of the drug.
Time frame: Screening Days -30 to Day 182 post dose/Early Termination
Suicidality via Columbia-Suicide Severity Rating Scale (C-SSRS) [safety and tolerability]
C-SSRS score will be monitored throughout the trial to assess the safety and tolerability of drug
Time frame: Screening Days -30 to Day 182 post dose/Early Termination
Extrapyramidal Symptoms (EPS) Rating Scales
EPS score will be monitored to assess safety and tolerability of drug
Time frame: Screening Days -30 to Day 182 post dose/Early Termination
Investigator's Assessment of Injection Site
The injection site will be monitored to assess the safety and tolerability of drug
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Screening Days -30 to Day 182 post dose/Early Termination
Visual Analog Scale (VAS) Scores for Pain Perception
VAS score will be monitored to assess safety and tolerability of drug
Time frame: Day 1 to Day 28 post dose
Pharmacokinetics - Maximum plasma concentration (Cmax)
The maximum plasma concentration of drug at injection site will be assessed for plasma Aripiprazole and its major metabolite dehydro-aripiprazole
Time frame: Day 1 to Day 182/Early Termination
Pharmacokinetics - time of maximum plasma concentration (tmax)
The amount of time that the maximum plasma concentration of drug at injection site will be assessed for plasma Aripiprazole and its major metabolite dehydro-aripiprazole
Time frame: Day 1 to Day 182/Early Termination
Pharmacokinetics - area under concentration-time curve (AUC) calculated from time zero to time t (AUCt)
AUCt will be assessed for plasma Aripiprazole and its major metabolite dehydro-aripiprazole to determine average concentration of drug over time
Time frame: Day 1 to Day 182/Early Termination
Pharmacokinetics - AUC calculated from time to infinity
AUCinfinity will be assessed for plasma Aripiprazole and its major metabolite dehydro-aripiprazole to determine total drug exposure over time
Time frame: Day 1 to Day 182/Early Termination
Pharmacokinetics - Terminal-phase elimination half-life (t1/2,z)
t1/2,z will be assessed for plasma Aripiprazole and its major metabolite dehydro-aripiprazole to determine drug persistence in the body
Time frame: Day 1 to Day 182/Early Termination