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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 30, 2014