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

November 11, 2009
April 15, 2010
November 2009
February 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01012310 on ClinicalTrials.gov Archive Site
pharmacokinetics of alternative formulations [ Time Frame: days 1-15 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Group Study To Investigate The Safety, Toleration And Pharmacokinetics Of Multiple Oral Doses Of PF-04531083 In Healthy Subjects
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

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).

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Healthy Volunteers
  • 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.
  • Experimental: Cohort 1
    Intervention: Drug: PF-04531083 or Placebo
  • Experimental: Cohort 2
    Intervention: Drug: PF-04531083 or Placebo
  • Experimental: Cohort 3
    Intervention: Drug: PF-04531083 or Placebo
  • Experimental: Cohort 4
    Intervention: Drug: PF-04531083 or Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
April 2010
February 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01012310
B1351002
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP