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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PF-04173127

Group Type EXPERIMENTAL

PF-04171327

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Prednisolone

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Solution Placebo

Group Type SHAM_COMPARATOR

Placebo Solution

Intervention Type DRUG

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

Group Type EXPERIMENTAL

PF-04171327 Tablet

Intervention Type DRUG

A single 10 mg dose of PF-04171327 tablet formulation will be administered orally to volunteers in Part 2 of this study.

Interventions

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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.

Intervention Type 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

Intervention Type DRUG

Placebo

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

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes