A Study To Examine The Safety, Pharmacokinetics And Pharmacodynamics Of PF-03635659 In Patients With Chronic Obstructive Pulmonary Disease

NCT01033487 | Completed Phase 2 Results

• 1 other identifier: B0431010
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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).

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Obstructive Airway Disease; COPD

Keywords

Safety; Pharmacokinetics; Pharmacodynamics; PF-03635659; COPD

Outcome Measures

Primary Outcomes (9)

• Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1)

  FEV1 was the mean volume of air that can be forced out in 1 second after taking a deep breath. Trough FEV1 was calculated as the average of the largest FEV1 value from 3 readings recorded at 24 hours (hrs) and 24.5 hrs post-dose. Baseline FEV1 value was calculated as average of 2 largest pre-dose readings on Day 1 for each period. Change from baseline in trough FEV1 was the difference between trough FEV1 and baseline FEV1.

  Baseline, 24, 24.5 hrs post-dose

• Maximum Observed Plasma Concentration (Cmax)

  1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose

• Dose Normalized Maximum Observed Plasma Concentration

  Cmax was normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).

  1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose

• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

  Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).

  1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose

• Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration

  Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). AUClast was normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).

  1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose

• Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC(0-∞)]

  AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It was obtained from AUC (0 - t) plus AUC (t-∞).

  1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose

• Dose Normalized Area Under the Curve From Time Zero Extrapolated to Infinite Time

  AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It was obtained from AUC (0 - t) plus AUC (t-∞). AUC (0-∞) was dose normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).

  1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose

• Plasma Decay Half-Life (t1/2)

  Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose

Secondary Outcomes (4)

• Peak Forced Expiratory Volume in 1 Second (FEV1)

  Baseline up to 48 hrs post-dose

• Weighted Average Forced Expiratory Volume in 1 Second (FEV1) Response

  Baseline up to 24.5 hrs post-dose

• Change From Baseline in Force Vital Capacity (FVC)

  Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs post-dose

• Change From Baseline in Inspiratory Capacity (IC)

  Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs pot-dose

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Drug: placebo

active comparator

ACTIVE COMPARATOR

Drug: active comparator

PF-03635659

EXPERIMENTAL

Drug: Low Dose PF-03635659; Drug: Mid Dose PF-03635659; Drug: High Dose PF-03635659

Interventions

placebo DRUG

oral inhaled formulation, single dose

Placebo

active comparator DRUG

oral inhaled formulation, single dose

active comparator

Low Dose PF-03635659 DRUG

oral inhaled formulation, single dose, low dose

PF-03635659

Mid Dose PF-03635659 DRUG

oral inhaled formulation, single dose, mid dose

PF-03635659

High Dose PF-03635659 DRUG

oral inhaled formulation, single dose, high dose

PF-03635659

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Berlin, 10117, Germany

Location

Related Links

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

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2009
• First Posted: December 16, 2009
• Study Start: January 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: February 19, 2016
• Results First Posted: February 19, 2016

Record last verified: 2016-01

Locations

DE (1)