This is an open-label, single-dose study in healthy male subjects to investigate the absorption, metabolism, and excretion (AME) of KW-6356.
Subjects will be screened to assess their eligibility to enter the study within approximately 4 weeks prior to dose administration. Subjects will be confined to the Clinical Research Unit (CRU) for their entire participation in this study. Eight subjects will be enrolled to allow 6 subjects to complete the study. Each subject will report to the CRU and be confined from Day -1 (the day before dosing) through at least Day 8 (168 hours postdose). A single dose of study drug will be administered on Day 1 (0 hour). On Day 8, subjects can be asked to remain as a resident within the CRU for an additional period to allow for ongoing 24-hour urine, fecal, and blood sample collections. These collections can continue up to a maximum of 336 hours postdose (Day 15). Subjects can be discharged prior to Day 15 if the following individual subject discharge criteria have been satisfied: ≥ 90% of the 14C dose recovered in combined urine and feces, and ≤ 1% of the total radioactive dose is recovered in combined excreta (urine and feces) in 3 consecutive 24-hour periods in which a fecal sample is provided.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
8
Single oral dose of KW-6356
Covance Clinical Research Unit Inc.
Madison, Wisconsin, United States
Cmax
Maximum observed concentration (KW-6356 in plasma and total radioactivity in plasma and blood).
Time frame: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
tmax
Time of maximum observed concentration (KW-6356 in plasma and total radioactivity in plasma and blood).
Time frame: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
AUC0-t
Area under the drug concentration-time curve from time zero to the last quantifiable concentration (KW-6356 in plasma and total radioactivity in plasma and blood).
Time frame: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
%AUCextra
Percentage of estimated part for the calculation of AUC0-∞ (KW-6356 in plasma and total radioactivity in plasma and blood).
Time frame: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
t1/2
Elimination half-life (KW-6356 in plasma and total radioactivity in plasma and blood).
Time frame: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
kel
Elimination rate constant (KW-6356 in plasma and total radioactivity in plasma and blood).
Time frame: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
Vz/F
Apparent volume of distribution during terminal phase (KW-6356 in plasma).
Time frame: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
CL/F
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Apparent oral clearance (KW-6356 in plasma).
Time frame: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
MRT
Mean residence time (KW-6356 in plasma).
Time frame: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
Whole blood/plasma concentration ratio (total radioactivity in blood and plasma).
Time frame: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
Aeurine
Cumulative amount excreted in urine (total radioactivity in urine).
Time frame: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
feurine
Fraction of the dose administered excreted in urine (total radioactivity in urine).
Time frame: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
Aefeces
Cumulative amount excreted in feces (total radioactivity in feces).
Time frame: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
fefeces
Fraction of the dose administered excreted in feces (total radioactivity in feces).
Time frame: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
Aetotal
Total amount excreted (total radioactivity in urine and feces).
Time frame: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
fetotal
Fraction of the dose administered excreted in urine and feces (total radioactivity in urine and feces).
Time frame: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
Metabolic profiling and identification (plasma, urine, and feces).
Time frame: Pre-dose up to 168 hours post dose, up to 336 hours post dose.
Adverse Events
Number of subjects experiencing an adverse event related to treatment.
Time frame: From screening through study completion, an average of 6 weeks.
Severe adverse events.
Number of subjects experiencing a severe adverse event related to treatment.
Time frame: From screening through study completion, an average of 6 weeks.
Serum chemistry, hematology, and urinalysis.
Number of subjects with abnormal laboratory values that are related to treatment.
Time frame: From screening through study completion, an average of 6 weeks.
Vital signs
Number of subjects with abnormal vital signs that are related to treatment.
Time frame: From screening through study completion, an average of 6 weeks.
12-lead ECG.
Number of subjects with abnormal ECG that are related to treatment.
Time frame: From screening through study completion, an average of 6 weeks.
Physical examination.
Number of subjects with abnormal physical exam findings that are related to treatment.
Time frame: From screening through study completion, an average of 6 weeks.