Multiple Dose Escalation Trial Of PF-04308515 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

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-11-30

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-04308515 in healthy volunteers for 14 days as well as one oral dose of a tablet formulation administered for 1 day.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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(Part 1) PF-04308515

Group Type EXPERIMENTAL

PF-04308515

Intervention Type DRUG

PF-04308515 will be provided as an oral solution administered at doses of 3, 10, 30 and 100 mg. If an optional cohort is needed the dose would not exceed the established toxicokinetic exposure limits. Solution will be administered orally once daily for 14 days.

(Part 1) Solution Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo solution will be administered to those volunteers who are randomized to the placebo arm. Placebo solution will be administered orally once daily for 14 days.

(Part 2) PF-04308515 Tablet

Group Type EXPERIMENTAL

PF-04308515 Tablet

Intervention Type DRUG

Tablet formulation to administer a 20 mg dose will be administered to volunteers in Part 2. The study medication will be administered orally once daily for 1 day.

Interventions

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PF-04308515

PF-04308515 will be provided as an oral solution administered at doses of 3, 10, 30 and 100 mg. If an optional cohort is needed the dose would not exceed the established toxicokinetic exposure limits. Solution will be administered orally once daily for 14 days.

Intervention Type DRUG

Placebo

Placebo solution will be administered to those volunteers who are randomized to the placebo arm. Placebo solution will be administered orally once daily for 14 days.

Intervention Type DRUG

PF-04308515 Tablet

Tablet formulation to administer a 20 mg dose will be administered to volunteers in Part 2. The study medication will be administered orally once daily for 1 day.

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
* Females are required to be surgically sterile

Exclusion Criteria

* Evidence or history of clinically significant disease
* Post-menopausal women
* History of intolerance or significant adverse effects with glucocorticoid therapy

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes