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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00812825
• Other study ID #: A9391002
• Status: Completed
• Phase: Phase 1
• First received: December 19, 2008
• Last updated: August 11, 2009
• Start date: January 2009
• Est. completion date: July 2009

Study information

• Verified date: August 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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.
• 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
Tablets similar in appearance to prednisolone will be administered once daily for 14 days.
• 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.
• 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.

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of multiple doses of PF-04171327		14 days	Yes
Primary	Determination of pharmacokinetic parameters of PF-04171327 after multiple doses		14 days	No
Primary	Assessment of the pharmacodynamic effects of PF-04171327 on chemical and metabolic biomarkers		14 days	No
Primary	Evaluation of the pharmacokinetic parameters of a single 10 mg dose of PF-04171327 tablet		1 day	No
Secondary	To characterize the pharmacodynamic effects of prednisolone		14 days	No

External Links

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