Skip to main content
OpenTrials
Completed

NCT Number: NCT01012310

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Brussels, 1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-04531083 or Placebo

Drug

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

Primary outcomes

  1. Pharmacokinetics of PF-04531083 Cmax, Tmax, AUCtau, AUCinf, T1/2, accumulation index

    Time frame: days 1-15

  2. 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)

    Time frame: days 1-15

Secondary outcomes

  1. pharmacokinetics of alternative formulations

    Time frame: days 1-15

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Double Blind, 3rd Party Open, Placebo Controlled, Dose Escalating, Parallel Group Study To Investigate The Safety, Toleration And Pharmacokinetics Of Multiple Oral Doses Of PF-04531083 In Healthy Subjects

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 13, 2009
Registry last updated
Apr 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.