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

NCT01012310 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2010-04-16

No results posted yet for this study

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).

Conditions

  • Healthy Volunteers

Interventions

DRUG

PF-04531083 or Placebo

Subjects will receive multiple oral doses of less than or equal to 100mg PF-04531083 or placebo for 14 days.

DRUG

PF-04531083 or Placebo

Subjects will receive multiple oral doses of less than or equal to 300mg PF-04531083 or placebo for 14 days.

DRUG

PF-04531083 or Placebo

Subjects will receive multiple oral doses of less than or equal to 500mg PF-04531083 or placebo for 14 days.

DRUG

PF-04531083 or Placebo

A fourth cohort may be used to investigate alternative dosing regimens, formulations or food effects.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-02-28
Completion
2010-04-30

Countries

  • Belgium

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01012310 on ClinicalTrials.gov