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A Phase 1 Multiple-Dose Escalation and Single Dose (Tablet) Study of PF-04171327 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00812825
First received: December 19, 2008
Last updated: August 11, 2009
Last verified: August 2009

December 19, 2008
August 11, 2009
January 2009
July 2009   (final data collection date for primary outcome measure)
  • Safety and tolerability of multiple doses of PF-04171327 [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
  • Determination of pharmacokinetic parameters of PF-04171327 after multiple doses [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Assessment of the pharmacodynamic effects of PF-04171327 on chemical and metabolic biomarkers [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Evaluation of the pharmacokinetic parameters of a single 10 mg dose of PF-04171327 tablet [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00812825 on ClinicalTrials.gov Archive Site
To characterize the pharmacodynamic effects of prednisolone [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Phase 1 Multiple-Dose Escalation and Single Dose (Tablet) Study of PF-04171327 in Healthy Volunteers
A Phase 1, Active and Placebo-Controlled, Multiple-Dose Escalation Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04171327 (Part 1), and a Single Dose Pharmacokinetic Assessment of a Tablet Formulation (Part 2) in Healthy Volunteers

The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics (how the drug effects certain target sites of activity in the body) of escalating doses of oral PF-04171327 in healthy volunteers for 14 days (Part 1). Part 2 will evaluate the pharmacokinetics of a single 10 mg dose of the PF-04171327 tablet in healthy volunteers.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Healthy Volunteers
  • Drug: PF-04171327
    PF-0417327 will be provided as an oral solution administered at doses of 1, 3, 10 and 30 mg. If an additional cohort is required, the dose selected will not exceed 100 mg. Solution will be administered once daily for 14 days.
  • Drug: Prednisolone
    Oral doses of prednisolone (5, 10, and 20 mg) will be administered to the first three cohorts. The fourth cohort will receive between 1 and 20 mg to be determined after the third cohort completes dosing. If an additional cohort is required, the dose selected will not exceed 40 mg. Prednisolone tablets will be administered once daily for 14 days
  • Drug: Placebo
    Tablets similar in appearance to prednisolone will be administered once daily for 14 days.
  • Drug: Placebo Solution
    Placebo solution will be administered to those volunteers who are randomized to the placebo or prednisolone arms. This will be administered orally each day for 14 days.
  • Drug: PF-04171327 Tablet
    A single 10 mg dose of PF-04171327 tablet formulation will be administered orally to volunteers in Part 2 of this study.
  • Experimental: PF-04173127
    Intervention: Drug: PF-04171327
  • Active Comparator: Prednisolone
    Intervention: Drug: Prednisolone
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Sham Comparator: Solution Placebo
    Intervention: Drug: Placebo Solution
  • Experimental: PF-04171327 Tablet
    Intervention: Drug: PF-04171327 Tablet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
July 2009
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy males between 18 and 55 years, inclusive.
  • Healthy females between 18 and 44 years, inclusive.

Exclusion Criteria:

  • Evidence or history of clinically significant disease;
  • Post-menopausal women;
  • History of intolerance or significant adverse effects with glucocorticoids. therapy.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00812825
A9391002
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2009

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