A phase 1, open-label, non-randomized, 2-period, fixed sequence study to investigate the absorption, metabolism and excretion of [14C-PF-04965842] and to assess the absolute bioavailability and fraction absorbed of PF-04965842 in healthy male subjects using a 14C-microtracer approach.

Completed

• Conditions: eczeem; auto-immune disease; eczema; 10003816

• Registration Number: NL-OMON45258
• Lead Sponsor: Pfizer Inc.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

healthy male subjects
18 - 55 years, inclusive
BMI 17.5 - 30.5 kilograms/meter2, inclusive

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 rate and extent of radioactivity excretion of PF-04965842<br /><br>and drug related material.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To identify the metabolites of PF-04965842 in plasma, urine and feces, if<br /><br>possible.<br /><br>To determine the pharmacokinetics of PF-04965842 following IV and oral<br /><br>administration of PF-04965842.<br /><br>To determine the oral absolute bioavailability (F) of PF-04965842 following<br /><br>single dose administration under fasted condition.<br /><br>To determine the fraction of PF-04965842 dose absorbed (Fa).<br /><br>To determine the safety and tolerability of PF-04965842 following simultaneous<br /><br>oral/IV administration.</p><br>