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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00812825
Recruitment Status : Completed
First Posted : December 22, 2008
Last Update Posted : August 12, 2009
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: PF-04171327 Drug: Prednisolone Drug: Placebo Drug: Placebo Solution Drug: PF-04171327 Tablet Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : January 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Arm Intervention/treatment
Experimental: PF-04173127 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.

Active Comparator: Prednisolone 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

Placebo Comparator: Placebo Drug: Placebo
Tablets similar in appearance to prednisolone will be administered once daily for 14 days.

Sham Comparator: Solution Placebo 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.

Experimental: PF-04171327 Tablet 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.

Primary Outcome Measures :
  1. Safety and tolerability of multiple doses of PF-04171327 [ Time Frame: 14 days ]
  2. Determination of pharmacokinetic parameters of PF-04171327 after multiple doses [ Time Frame: 14 days ]
  3. Assessment of the pharmacodynamic effects of PF-04171327 on chemical and metabolic biomarkers [ Time Frame: 14 days ]
  4. Evaluation of the pharmacokinetic parameters of a single 10 mg dose of PF-04171327 tablet [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. To characterize the pharmacodynamic effects of prednisolone [ Time Frame: 14 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00812825

Pfizer Investigational Site
Bruxelles, Belgium, 1070
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00812825     History of Changes
Other Study ID Numbers: A9391002
First Posted: December 22, 2008    Key Record Dates
Last Update Posted: August 12, 2009
Last Verified: August 2009

Keywords provided by Pfizer:
Safety Tolerability Pharmacokinetics/pharmacodynamics

Additional relevant MeSH terms:
Pharmaceutical Solutions
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents