This will be a Phase 1, open-label, single dose study of the Absorption, Metabolism, and Excretion of CYC065 in healthy male subjects.
Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the dose administration. Subjects will be admitted into the study site on Day -1 and be confined to the study site until at least Day 8 (168 hours post dose). On Day 1, subjects will receive a single oral dose of \[14C\]-CYC065. Subjects will be discharged if the following discharge criteria are met: plasma radioactivity levels below the limit of quantitation for 2 consecutive collections, ≥90% mass balance recovery, and ≤1% of the total radioactive dose is recovered in combined excreta (urine and feces) in 2 consecutive 24-hour periods. If discharge criteria are not met by Day 8, subjects will remain in the study site until all discharge criteria are met up to a maximum of Day 15.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Open-label Study of the Absorption, Metabolism, and Excretion of \[14C\]-CYC065 Following a Single Oral Dose in Healthy Male Subjects
Labcorp Clinical Research Unit
Madison, Wisconsin, United States
The routes, rates of elimination, and mass balance
Total radioactivity from \[14C\]-CYC065 recovery (fet1t2) in urine and feces
Time frame: Up to Day 15
AUC for CYC065 in plasma
To characterize the PK of CYC065 and total radioactivity following administration of \[14C\]CYC065 to healthy subjects
Time frame: Up to Day 15
Cmax for CYC065 in plasma
To characterize the PK of CYC065 and total radioactivity following administration of \[14C\]CYC065 to healthy subjects
Time frame: Up to Day 15
Tmax for CYC065 in plasma
To characterize the PK of CYC065 and total radioactivity following administration of \[14C\]CYC065 to healthy subjects
Time frame: Up to Day 15
t½ for CYC065 in plasma
To characterize the PK of CYC065 and total radioactivity following administration of \[14C\]CYC065 to healthy subjects
Time frame: Up to Day 15
Concentration of CYC065 metabolites
To determine, where possible, the quantitative metabolite profiles in plasma, urine, and feces after \[14C\]CYC065
Time frame: Up to Day 15
Incidence and severity of AEs
To assess the safety and tolerability of \[14C\]CYC065 when administered to healthy subjects
Time frame: Up to Day 15
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