Single-dose Study of [14C]PF-05221304 Metabolism and Excretion in Healthy Adult Male Subjects

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: [14C]PF-05221304


Participation Criteria
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Eligibility Criteria
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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: 1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, allergic disease or clinical findings.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Product<br>[14C]PF-05221304 | Drug: [14C]PF-05221304<br>* a single oral dose of [14C]PF-05221304 (50 mg/100 µCi liquid formulation)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mass Balance | Cumulative recovery of urinary, fecal, and total excretion of radioactivity over time expressed as percentage of total radioactive dose administered | 0-96 hr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic profiling for PF-05221304 in plasma, urine, and feces | Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in plasma, urine and feces | 0-96 hr | 
| Radioactivity AUClast | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for radioactivity | 0-96 hr | 
| Plasma PF-05221304 AUClast | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05221304 | 0-96 hr | 
| Radioactivity AUCinf | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for radioactivity | 0-96 hr | 
| Plasma PF-05221304 AUCinf | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for PF-05221304 | 0-96 hr | 
| Radioactivity Cmax | Maximum Observed Plasma Concentration (Cmax) for radioactivity | 0-96 hr | 
| Plasma PF-05221304 Cmax | Maximum Observed Plasma Concentration (Cmax) for PF-05221304 | 0-96 hr | 
| Radioactivity Tmax | Time to Reach Maximum Observed Plasma Concentration for radioactivity | 0-96 hr | 
| Plasma PF-05221304 Tmax | Time to Reach Maximum Observed Plasma Concentration for PF-05221304 | 0-96 hr | 
| Radioactivity t1/2 | Plasma Decay Half-Life (t1/2) for radioactivity | 0-96 hr | 
| Plasma PF-05221304 t1/2 | Plasma Decay Half-Life (t1/2) for PF-05221304 | 0-96 hr | 
| Number of subjects experiencing an adverse event | Assessment by physical examinations, adverse event monitoring, clinical laboratory measurements, vital signs and ECG. Treatment-related AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity. Treatment-emergent are events between dosing with study drug and up to 28 days after that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug was assessed by the investigator (Yes/No). Subjects with multiple occurrences of an AE within a category were counted once within the category. | Up to 28 days post dosing of IP on Day 1 |