Multiple Dose Healthy Volunteer Safety Pharmacokinetics Study - Full Text View

Purpose

Multiple dose safety and pharmacokinetics in healthy male subjects

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: PF03635659	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment
Official Title:	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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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. [ Time Frame: 3 Weeks ] [ Designated as safety issue: Yes ]
Pharmacokinetics: Plasma: Cmax, Tmax, AUCinf, AUCτ, t½, accumulation ratio, linearity ratio. [ Time Frame: 3 Weeks ] [ Designated as safety issue: No ]
Pharmacodynamics: Salivary flow rate [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	September 2008
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Cohort 1 200 mcg	Drug: PF03635659 Inhaled doses of 200 mcgQD
Experimental: Cohort 2 600 mcg	Drug: PF03635659 Inhaled doses of 600 mcg QD
Experimental: Cohort 3 1000 mcg	Drug: PF03635659 Inhaled doses of 1000 mcg QD
Experimental: Cohort 4 Dose to be decided	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 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.

Eligibility

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00864786

Locations

Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1070

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00864786 History of Changes
Other Study ID Numbers:	B0431002
Study First Received:	December 22, 2008
Last Updated:	March 20, 2009
Health Authority:	Belgium: Institutional Review Board

Keywords provided by Pfizer:

Multiple dose safety and pharmacokinetics study

Additional relevant MeSH terms:

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 13, 2013