Multiple Dose Healthy Volunteer Safety Pharmacokinetics Study

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00864786
First received: December 22, 2008
Last updated: March 20, 2009
Last verified: March 2009
  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:


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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on August 19, 2014