NCT03448172
Completed
Phase 1
A Phase 1, Open Label, Single-period, Non-randomized Study To Evaluate The Pharmacokinetics, Excretion, Mass Balance, And Metabolism Of [14c]Pf-05221304 Administered Orally To Healthy Adult Male Subjects
Overview
- Phase
- Phase 1
- Intervention
- [14C]PF-05221304
- Conditions
- Healthy
- Sponsor
- Pfizer
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Mass Balance
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of the study is to characterize the absorption, distribution, metabolism, and excretion (ADME) of a single oral dose of [14C]PF-05221304 in Healthy Adult Male Subjects
Investigators
Eligibility Criteria
Inclusion Criteria
- •Ages of 18 and 45 years, inclusive.
- •Body mass index (BMI) of \>= 17.5 and \<= 30.4 kg/m2
- •Total body weight \> 50 kg (110 lb).
Exclusion Criteria
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, allergic disease or clinical findings.
Arms & Interventions
Investigational Product
\[14C\]PF-05221304
Intervention: [14C]PF-05221304
Outcomes
Primary Outcomes
Mass Balance
Time Frame: 0-96 hr
Cumulative recovery of urinary, fecal, and total excretion of radioactivity over time expressed as percentage of total radioactive dose administered
Secondary Outcomes
- Radioactivity Cmax(0-96 hr)
- Plasma PF-05221304 Tmax(0-96 hr)
- Radioactivity t1/2(0-96 hr)
- Number of subjects experiencing an adverse event(Up to 28 days post dosing of IP on Day 1)
- Metabolic profiling for PF-05221304 in plasma, urine, and feces(0-96 hr)
- Radioactivity AUClast(0-96 hr)
- Plasma PF-05221304 Cmax(0-96 hr)
- Radioactivity Tmax(0-96 hr)
- Plasma PF-05221304 AUClast(0-96 hr)
- Radioactivity AUCinf(0-96 hr)
- Plasma PF-05221304 AUCinf(0-96 hr)
- Plasma PF-05221304 t1/2(0-96 hr)
Study Sites (1)
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