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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00812825

Collaborator

(none)

Enrollment

Location

Arms

5.9

Duration (Months)

13.1

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Jan 1, 2009

Actual Primary Completion Date :

Jul 1, 2009

Actual Study Completion Date :

Jul 1, 2009

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Safety and tolerability of multiple doses of PF-04171327 [14 days]
Determination of pharmacokinetic parameters of PF-04171327 after multiple doses [14 days]
Assessment of the pharmacodynamic effects of PF-04171327 on chemical and metabolic biomarkers [14 days]
Evaluation of the pharmacokinetic parameters of a single 10 mg dose of PF-04171327 tablet [1 day]

Secondary Outcome Measures

To characterize the pharmacodynamic effects of prednisolone [14 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Bruxelles		Belgium	1070

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00812825

Other Study ID Numbers:

A9391002

First Posted:

Dec 22, 2008

Last Update Posted:

Aug 12, 2009

Last Verified:

Aug 1, 2009

Keywords provided by , ,

Safety Tolerability Pharmacokinetics/pharmacodynamics

Additional relevant MeSH terms:

Prednisolone

Study Results

No Results Posted as of Aug 12, 2009