Multiple Dose Healthy Volunteer Safety Pharmacokinetics Study

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.

Multiple dose safety and pharmacokinetics in healthy male subjects

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: PF03635659; Drug: PF03635659; Drug: PF03635659; Drug: PF03635659

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, 1070
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: December 22, 2008
• First Submitted That Met QC Criteria: March 18, 2009
• First Posted (Estimate): March 19, 2009

Study Record Updates

• Last Update Posted (Estimate): March 23, 2009
• Last Update Submitted That Met QC Criteria: March 20, 2009
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Keywords: Multiple dose safety and pharmacokinetics study
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: B0431002