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

Phase 1

Completed

• Conditions: Human Immunodeficiency Virus (HIV)
• Interventions: Drug: PF-04776548

• Registration Number: NCT01045317
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-08
• Study First Submitted QC: 2010-01-08
• Study First Posted: 2010-01-11
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-01
• Last Update Posted: 2010-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intravenous or oral administration	PF-04776548	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Safety and toleration: adverse events will also be reported.	14 days

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Ruddington Fields, Nottingham, United Kingdom