Multiple Dose Healthy Volunteer Safety Pharmacokinetics Study

Phase 1

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: PF03635659

• Registration Number: NCT00864786
• Lead Sponsor: Pfizer

Brief Summary

Multiple dose safety and pharmacokinetics in healthy male subjects

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-12-22
• Status Verified: 2009-03
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Study First Submitted QC: 2009-03-18
• Study First Posted: 2009-03-19
• Last Update Submitted: 2009-03-20
• Last Update Posted: 2009-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	PF03635659	200 mcg
Cohort 2	PF03635659	600 mcg
Cohort 3	PF03635659	1000 mcg
Cohort 4	PF03635659	Dose to be decided
Cohort 5	PF03635659	Dose to be decided

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics: Plasma: Cmax, Tmax, AUCinf, AUCτ, t½, accumulation ratio, linearity ratio.	3 Weeks
Pharmacodynamics: Salivary flow rate	3 weeks
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Bruxelles, Belgium