A Phase 1 Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03526299 In Healthy Adult 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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-01-31

Brief Summary

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The purpose of this study is to investigate safety and toleration of multiple inhaled doses as well as the time course of PF-03526299 concentration in the blood following dosing by dry powder inhaler.

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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

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PF-03526299 1.396 mg

Group Type EXPERIMENTAL

PF-03526299

Intervention Type DRUG

dry powder for inhalation, 1.396 mg, BID for 14 days

PF-03526299 4mg

Group Type EXPERIMENTAL

PF-03526299

Intervention Type DRUG

dry powder for inhalation, 4 mg, BID for 14 days

Interventions

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PF-03526299

dry powder for inhalation, 1.396 mg, BID for 14 days

Intervention Type DRUG

PF-03526299

dry powder for inhalation, 4 mg, BID for 14 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male subjects and females of non-childbearing potential between the ages of 21 and 55 years.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m\^2; and a total body weight \>50 kg (110 lbs).
* Subjects who had a normal chest X-ray in the previous 6 months prior to Screening

Exclusion Criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* A positive urine drug screen.
* History of regular alcohol consumption exceeding 21 drinks/week for males and 14 drinks/week for females.

Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes