A Phase 1 Single-Dose Escalation Study 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

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-01-31

Brief Summary

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The purpose of this study is to determine the safety, tolerability, pharmacokinetics (understanding how a drug is absorbed and moves through the body) and pharmacodynamics (understanding the effects of a drug on certain target sites of activity in the body).

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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

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PF-04308515

Group Type EXPERIMENTAL

PF-04308515

Intervention Type DRUG

Oral solution/suspension 0.1 mg up to potentially 350 mg QD at a single dose.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo solution/suspension to match active drug QD at a single dose.

Interventions

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PF-04308515

Oral solution/suspension 0.1 mg up to potentially 350 mg QD at a single dose.

Intervention Type DRUG

Placebo

Placebo solution/suspension to match active drug QD at a single dose.

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.
* Women need to be surgically sterile

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes