Clinical trial NCT01033487: A Study To Examine The Safety, Pharmacokinetics And Pharmacodynamics Of PF-03635659 In Patients With Chronic Obstructive Pulmonary Disease
Official title: A Phase 2A, Double Blind, Placebo-Controlled, Single Dose, 5-Way Crossover Study Assessing The Pharmacodynamic, Pharmacokinetic And Safety Profiles Of Oral Inhaled PF-03635659 In Patients With Moderate Chronic Obstructive Pulmonary Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Chronic Obstructive Airway Disease
COPD
Keywords: Safety
Pharmacokinetics
Pharmacodynamics
PF-03635659
COPD
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-12-16
Enrollment: 22
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: PF-03635659 is being developed for the treatment of chronic obstructive pulmonary disease. This is a study to examine the safety, pharmacokinetics and pharmacodynamics of PF-03635659 in patients with Chronic Obstructive Pulmonary Disease (COPD).


Eligibility criteria: Inclusion Criteria:

* Male or female (women of non-childbearing potential) subjects between the ages of 40 and 80 years, inclusive with a diagnosis of moderate COPD (GOLD, 2007 update) and who meet the following criteria for GOLD stage II disease
* Body Mass Index (BMI) of less than 35.5 kg/m2; and a total body weight \>40 kg (88 lbs).
* Current smokers, or ex-smokers who have abstained from smoking for at least 6 months

Exclusion Criteria:

* Subjects having more than 2 exacerbations requiring treatment with oral steroids or hospitalization for the treatment of COPD in the previous year.
* History of lower respiratory tract infection or significant disease instability during the month preceding screening or during the period between screening and randomization.

Primary outcomes:
measure: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Baseline, 24, 24.5 hrs post-dose
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
measure: Dose Normalized Maximum Observed Plasma Concentration
timeFrame: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
measure: Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration
timeFrame: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC(0-∞)]
timeFrame: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
measure: Dose Normalized Area Under the Curve From Time Zero Extrapolated to Infinite Time
timeFrame: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
Secondary outcomes:
measure: Peak Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Baseline up to 48 hrs post-dose
measure: Weighted Average Forced Expiratory Volume in 1 Second (FEV1) Response
timeFrame: Baseline up to 24.5 hrs post-dose
measure: Change From Baseline in Force Vital Capacity (FVC)
timeFrame: Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs post-dose
measure: Change From Baseline in Inspiratory Capacity (IC)
timeFrame: Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs pot-dose
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: