Group Study To Investigate The Safety, Toleration And Pharmacokinetics Of Multiple Oral Doses Of PF-04531083 In Healthy Subjects

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: PF-04531083 or Placebo

• Registration Number: NCT01012310
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to determine the safety and toleration of single and multiple doses of PF-04531083. (To investigate the plasma and urinary pharmacokinetics of PF-04531083 and its metabolites, following single and multiple dose administration in healthy male and/or female subjects; and to determine whether PF-04531083 raises levels of enzymes involved in metabolism of other drugs following multiple dosing).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-11
• Study First Submitted QC: 2009-11-12
• Study First Posted: 2009-11-13
• Primary Completion: 2010-02
• Status Verified: 2010-04
• Study Completion: 2010-04
• Last Update Submitted: 2010-04-15
• Last Update Posted: 2010-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Healthy male and/or female subjects btween the ages of 18-55 years
• Body Mass Index (BMI) of 15.5 to 30.5 and a total body weight greater than 50kg (110 lbs).

Exclusion Criteria

• Evidence or history of clinically signifcant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
• A positive urine drug screen.
• History of regular alcohol consumption exceeding 21 drinks/week within 6 months of screening
• Use of tobacco or nicotine containing products in excess of the equivalent of 5 cigarettes per day.
• Pregnant or nursing females; females of childbearing potentioal who are unwilling or unable to use an acceptable method on contraception.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	PF-04531083 or Placebo	-
Cohort 2	PF-04531083 or Placebo	-
Cohort 3	PF-04531083 or Placebo	-
Cohort 4	PF-04531083 or Placebo	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of PF-04531083 Cmax, Tmax, AUCtau, AUCinf, T1/2, accumulation index	days 1-15
Safety of subjects following multiple dosing of PF-04531083 (adverse events, vital signs measurements, telemetry, 12-lead ECGs, physical examination findings, blood and urine safety tests)	days 1-15

Secondary Outcome Measures

Name	Time	Method
pharmacokinetics of alternative formulations	days 1-15

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Bruxelles, Belgium