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

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NCT00812825

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Study Location
Pfizer Investigational Site
Bruxelles, , 1070, Belgium
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy males between 18 and 55 years, inclusive.

- Healthy females between 18 and 44 years, inclusive.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Evidence or history of clinically significant disease;


- Post-menopausal women;


- History of intolerance or significant adverse effects with glucocorticoids. therapy.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Phase 1 Multiple-Dose Escalation and Single Dose (Tablet) Study of PF-04171327 in Healthy Volunteers
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 11, 2009)		78
Original Estimated Enrollment  ICMJE
 (submitted: December 19, 2008)		80
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00812825
Other Study ID Numbers  ICMJE A9391002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2009

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