Multiple Dose Healthy Volunteer Safety Pharmacokinetics Study

Study Overview
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Brief Summary
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Multiple dose safety and pharmacokinetics in healthy male subjects

Official Title
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A Double Blind (3rd Party Open), Randomised, Placebo Controlled, Dose Escalating Study To Investigate The Safety, Toleration, Pharmacokinetics, And Pharmacodynamics Of Multiple Inhaled Doses Of PF-03635659 In Healthy Male Subjects.

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: PF03635659
* Drug: PF03635659
* Drug: PF03635659
* Drug: PF03635659
* Drug: PF03635659


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>200 mcg | Drug: PF03635659<br>* Inhaled doses of 200 mcgQD<br>|
| Experimental: Cohort 2<br>600 mcg | Drug: PF03635659<br>* Inhaled doses of 600 mcg QD<br>|
| Experimental: Cohort 3<br>1000 mcg | Drug: PF03635659<br>* Inhaled doses of 1000 mcg QD<br>|
| Experimental: Cohort 4<br>Dose to be decided | Drug: PF03635659<br>* 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.<br>|
| Experimental: Cohort 5<br>Dose to be decided | Drug: PF03635659<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and toleration: Adverse events, vital signs measurements (supine and standing), 12-lead ECGs, spirometry (FEV1, FVC), laboratory safety tests, physical examination, and subject-reported dry mouth assessment. |  | 3 Weeks | 
| Pharmacokinetics: Plasma: Cmax, Tmax, AUCinf, AUCτ, t½, accumulation ratio, linearity ratio. |  | 3 Weeks | 
| Pharmacodynamics: Salivary flow rate |  | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple dose safety and pharmacokinetics study