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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01012310
First received: November 11, 2009
Last updated: April 15, 2010
Last verified: April 2010
  Purpose

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).


Condition Intervention Phase
Healthy Volunteers
Drug: PF-04531083 or Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Pharmacokinetics of PF-04531083 Cmax, Tmax, AUCtau, AUCinf, T1/2, accumulation index [ Time Frame: days 1-15 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • pharmacokinetics of alternative formulations [ Time Frame: days 1-15 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: November 2009
Study Completion Date: April 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1 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.
Experimental: Cohort 2 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.
Experimental: Cohort 3 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.
Experimental: Cohort 4 Drug: PF-04531083 or Placebo
A fourth cohort may be used to investigate alternative dosing regimens, formulations or food effects.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01012310

Locations
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1070
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01012310     History of Changes
Other Study ID Numbers: B1351002
Study First Received: November 11, 2009
Last Updated: April 15, 2010
Health Authority: Belgium: Belgian Health Authority

Keywords provided by Pfizer:
pharmacokinetics safety tolerability multiple dosing

ClinicalTrials.gov processed this record on April 16, 2014