Radiolabel ADME (Absorption, Distribution, Metabolism, and Excretion) Study Of [14C] PF-00868554 In Healthy Adult Male Subjects
Phase 1
Completed
- Conditions
- HCV
- Interventions
- Drug: [14C]-PF-00868554
- Registration Number
- NCT00823745
- Lead Sponsor
- Pfizer
- Brief Summary
This is a phase 1 study to assess the routes of elimination of a single oral dose of \[14C\] PF-00868554 and to characterize the metabolic profile following single dose administration.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 7
Inclusion Criteria
- Male, healthy volunteers.
Exclusion Criteria
- Females.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 [14C]-PF-00868554 \[14C\]-PF-00868554
- Primary Outcome Measures
Name Time Method The amount of radioactivity recovered in urine and feces, as a percent of the dose. 7 weeks The amount of PF-00868554, expressed as a percent of total radioactivity, in plasma, urine, and feces. 7 weeks Identification and determination of relative abundance of the metabolites of PF-00868554 in plasma, urine, and feces. 7 weeks PK parameters: AUClast, AUCinf, maximum concentration (Cmax), time of maximum concentration (Tmax), and half-life (t1/2) to describe the single dose PK of a) total radioactivity in blood; b) total radioactivity in plasma; c) PF-00868554 in plasma. 7 weeks
- Secondary Outcome Measures
Name Time Method Safety endpoints including adverse events, clinical laboratory tests, vital signs and ECGs. 7 weeks
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Tacoma, Washington, United States