A phase 1, open-label, 2-period, fixed sequence, study to investigate the absorption, metabolism and excretion of 14C-PF-06650833 and to assess the absolute bioavailability and fraction absorbed of PF-06650833 in healthy male subjects using a 14C-microdose approach.
Completed
- Conditions
- Rheumatoid Arthritisautoimmune disease.10003816
- Registration Number
- NL-OMON44374
- Lead Sponsor
- Pfizer, inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
Inclusion Criteria
healthy male subjects
18 - 55 years of age
BMI 17.5 - 30.5 kilograms/meter2
Weight >50 kg
Exclusion Criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To characterize the rates and extent of excretion of total radioactivity in<br /><br>urine and feces after single oral administration of 14C-PF-06650833-LR.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To identify the metabolites of PF-06650833 in plasma, urine and feces, if<br /><br>possible.<br /><br>To determine the pharmacokinetics of PF-06650833 following IV and oral<br /><br>administration of PF-06650833.<br /><br>To determine renal clearance of PF-06650833.<br /><br>To determine the safety and tolerability of PF-06650833 following simultaneous<br /><br>oral/IV administration.</p><br>