A Study To Investigate The Clearance Of PF-04776548 From The Body Following A Very Low (Micro) Dose Of The Compound Using A Low Level Of Radiotracer To Help Quantify Expected Low Concentrations Of PF-04776548 In The Body

Study Overview
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Brief Summary
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To investigate the pharmacokinetics of PF-04776548 following administration of a micro-dose of PF-04776548 via both intravenous and oral routes.

Official Title
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An Exploratory, Open Label, Randomized, Parallel Group Study To Investigate The Pharmacokinetics Of Single Intravenous And Oral Micro Doses Of [14-C]-PF-04776548 In Healthy Male Subjects

Conditions
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Human Immunodeficiency Virus (HIV)

Intervention / Treatment
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* Drug: PF-04776548


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects between the ages of 18 and 65 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). 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). Any condition possibly affecting drug absorption (eg, gastrectomy). A positive urine drug screen. History of regular alcohol consumption exceeding 21 drinks/week (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening. Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intravenous or oral administration<br> | Drug: PF-04776548<br>* single intravenous or oral administration of 0.1mg PF-04776548.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: For IV dosing: Cmax, Tmax, AUClast, AUCinf, t½, CL, Vss. For oral dosing: Cmax, Tmax, Tlag, AUClast, AUCinf, t½, CL/F, Vz/F, F. |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and toleration: adverse events will also be reported. |  | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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micro-dose, pharmacokinetics, open label, PF-04776548