A phase 1, open-label, non-randomized, 2-period, fixed sequence study to investigate the absorption, distribution, metabolism and excretion of 14C-PF-06651600 and to assess the absolute bioavailability and fraction absorbed of PF-06651600 in healthy male participants using a 14C-microtracer approach
- Conditions
- autoimmune and inflammatory diseases100038161002321310035023
- Registration Number
- NL-OMON48152
- Lead Sponsor
- Pfizer, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
- healthy male subjects
- 18-55 yrs, inclusive
- BMI: 18.0-30.0 kg/m2, inclusive
- total bodyweight > 50 kg
1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
2. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy, appendectomy).
3. Known immunodeficiency disorder, including positive serology for human immunodeficiency virus (HIV) at screening, or a first degree relative with a hereditary immunodeficiency.
4. Infection with hepatitis B or hepatitis C viruses according to protocol specific testing algorithm.
a. For hepatitis B, all participants will undergo testing for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb). Participants who are HBsAg positive are not eligible for this study. Participants who are HBsAg negative but HBcAb positive will be reflex tested for hepatitis B surface antibody (HBsAb).
b. For hepatitis C, all participants will undergo testing for hepatitis C antibody (HCVAb) during Screening.
• Participants who are HCVAb positive will be reflex tested for hepatitis C RNA (HCV RNA). Participants who are HCVAb and HCV RNA positive are not eligible for the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Mass Balance: Cumulative recovery (%) of radioactivity in urine and feces.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Metabolic profiling/metabolite identification in plasma, urine and fecal<br /><br>sample.<br /><br><br /><br>- PK parameters of PF-06651600 from plasma concentration: Cmax, AUClast,<br /><br>AUCinf, Tmax, t* (half-life), CL (IV) & CL/F (Oral), Vss(IV) & Vz/F (Oral).<br /><br><br /><br>- PF-06651600 AUCinf from both oral PF-06651600 and IV 14C-PF-06651600 (Period<br /><br>B only) plasma data.<br /><br><br /><br>- Total 14C urine data following both IV (Period B) and oral (Period A)<br /><br>administration of 14C-PF-06651600 (quantification by AMS).<br /><br><br /><br>- Adverse event (AE) monitoring, physical examination, clinical laboratory<br /><br>measurements, vital signs.</p><br>