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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01045317

Enrollment

Registered

2010-01-11

Start date

2010-01-31

Completion date

2010-02-28

Last updated

2010-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Immunodeficiency Virus (HIV)

Keywords

micro-dose, pharmacokinetics, open label, PF-04776548

Brief summary

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

Interventions

DRUGPF-04776548

single intravenous or oral administration of 0.1mg PF-04776548.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	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

Measure	Time frame
Safety and toleration: adverse events will also be reported.	14 days

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026