Multiple Dose Safety Study of PF-04802540 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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-01-31

Brief Summary

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The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple ascending doses of PF-04802540 administered orally to healthy adult subjects.

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Detailed Description

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Evaluation of safety and pharmacokinetics

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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PF-04802540

Group Type EXPERIMENTAL

PF-04802540

Intervention Type DRUG

Multiple ascending doses for 10 days; planned doses include 5, 10 and 15 mg capsules q12 hours, doses may be adjusted based on accumulating data

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo capsules q12 hours for 10 days

Interventions

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PF-04802540

Multiple ascending doses for 10 days; planned doses include 5, 10 and 15 mg capsules q12 hours, doses may be adjusted based on accumulating data

Intervention Type DRUG

Placebo

Placebo capsules q12 hours for 10 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males or females of non-childbearing capacity aged 21 to 55 years inclusive at screening.
* Body mass index in the range of 18 to 30 kg/m2 and body weight\>45 kg.
* Healthy as determined by the investigator on the basis of screening evaluation.