Multiple Dose Healthy Volunteer Safety Pharmacokinetics Study

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-03-31

Brief Summary

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Multiple dose safety and pharmacokinetics in healthy male subjects

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Cohort 1

200 mcg

Group Type EXPERIMENTAL

PF03635659

Intervention Type DRUG

Inhaled doses of 200 mcgQD

Cohort 2

600 mcg

Group Type EXPERIMENTAL

PF03635659

Intervention Type DRUG

Inhaled doses of 600 mcg QD

Cohort 3

1000 mcg

Group Type EXPERIMENTAL

PF03635659

Intervention Type DRUG

Inhaled doses of 1000 mcg QD

Cohort 4

Dose to be decided

Group Type EXPERIMENTAL

PF03635659

Intervention Type DRUG

Inhaled dose to be decided based on all available data from previous cohorts. It will run if maximum tolerated dose is not identified from previous cohorts or if a lower dose is required to be investigated.

Cohort 5

Dose to be decided

Group Type EXPERIMENTAL

PF03635659

Intervention Type DRUG

Inhaled dose to be decided based on all available data from previous cohorts. It will run if maximum tolerated dose is not identified from previous cohorts or if a lower dose is required to be investigated.

Interventions

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PF03635659

Inhaled doses of 200 mcgQD

Intervention Type DRUG

PF03635659

Inhaled doses of 600 mcg QD

Intervention Type DRUG

PF03635659

Inhaled doses of 1000 mcg QD

Intervention Type DRUG

PF03635659

Inhaled dose to be decided based on all available data from previous cohorts. It will run if maximum tolerated dose is not identified from previous cohorts or if a lower dose is required to be investigated.

Intervention Type DRUG

PF03635659

Inhaled dose to be decided based on all available data from previous cohorts. It will run if maximum tolerated dose is not identified from previous cohorts or if a lower dose is required to be investigated.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight \>50 kg (110 lbs). A BMI lower limit of 17.5 kg/m2 may be rounded up to 18.0 kg/m2; a BMI upper limit of 30.5 kg/m2 may be rounded down to 30.0 kg/m2 and will be acceptable for inclusion.

Exclusion Criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening.
* Any condition possibly affecting drug absorption (eg, gastrectomy).

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes