Single Dose Study To Study The Absorption, Metabolism And Excretion Of PF-04991532

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the excretion balance, metabolic profile and the routes of excretion of [14C]PF-04991532 in healthy adult male subjects.

Official Title
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An Open Label, Single-Period, Phase 1 Study To Evaluate The Pharmacokinetics, Excretion, Mass Balance And Metabolism Of [14c]-PF-04991532 In Healthy Adult Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: PF-04991532


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests). Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg(110 lbs). An informed consent document signed and dated by the subject. Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or clinical findings at Screening. History of irregular bowel movements (eg, irritable bowel syndrome or frequent episodes of diarrhea or constipation). Any condition possibly affecting drug absorption (eg, appendectomy, gastrectomy).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: PF-04991532<br>* a single oral dose of [14C]PF-04991532 (450 mg/100 uCi suspension)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mass Balance: Urinary and fecal excretion of radioactivity over time expressed as a percentage of the total radioactive dose administered. |  | 0-168 hrs | 
| Metabolic Profiling/identification and determination of relative abundance of PF-04991532 and the metabolites of PF-04991532 in plasma, urine, and feces. |  | 0-168 hrs | 
| radioactivity AUC |  | 0-168 hrs | 
| plasma PF-04991532 AUC |  | 0-168 hrs | 
| radioactivity Cmax |  | 0-168 hrs | 
| plasma PF-04991532 Cmax |  | 0-168 hrs | 
| plasma PF-04991532 Tmax |  | 0-168 hrs | 
| radioactivity Tmax |  | 0-168 hrs | 
| plasma PF-04991532 t1/2 |  | 0-168 hrs | 
| radioactivity t1/2 |  | 0-168 hrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus, ADME