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

Human Immunodeficiency Virus (HIV) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01045317
• Other study ID #: B1711001
• Status: Completed
• Phase: Phase 1
• First received: January 8, 2010
• Last updated: April 1, 2010
• Start date: January 2010
• Est. completion date: February 2010

Study information

• Verified date: April 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Europe: European Medicines Agency (EMEA)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus (HIV)
• Immunologic Deficiency Syndromes

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Pfizer Investigational Site	Ruddington Fields	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Safety and toleration: adverse events will also be reported.		14 days	Yes

External Links

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