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A Study Estimating The Time Course Of PF-04764793 In The Blood Following Dosing By Oral Inhalation From Dry Powder Inhalers

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00928278
First received: June 24, 2009
Last updated: December 18, 2009
Last verified: December 2009
  Purpose

The purpose of this study is to investigate the time course of PF-04764793 concentration in the blood following dosing by oral inhalation from dry powder inhalers.


Condition Intervention Phase
Healthy
Drug: Treatment A
Drug: Treatment B
Drug: Treatment C
Drug: Treatment D
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Open Study To Estimate The Plasma Pharmacokinetics Of PF-04764793 Administered Via Oral Inhalation Using Dry Powder Inhalers.

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Plasma pharmacokinetic parameters: AUClast and Cmax [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma pharmacokinetic parameters: AUC0-12, AUC0-24, AUCinf, Tmax and terminal half-life. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: July 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A - PF-04764793
PF-04764793 using inhaler A
Drug: Treatment A
Inhaled, 300/150, single dose
Active Comparator: Treatment B - PF-04764793
PF-04764793 using inhaler B
Drug: Treatment B
Inhaled, 300/150, single dose
Experimental: Treatment C - PF-04764793
PF-04764793 using inhaler A
Drug: Treatment C
Inhaled, 300/150, single dose + oral activated charcoal block
Active Comparator: Treatment D - PF-04764793
PF-04764793 using inhaler B
Drug: Treatment D
Inhaled, 300/150, single dose + oral activated charcoal block

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and/or female subjects between the ages of 21 and 55 years.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m^2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • A positive urine drug screen.
  • History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males.
  • Pregnant or nursing females.
  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: NCT00928278

Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
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: NCT00928278     History of Changes
Obsolete Identifiers: NCT00977535
Other Study ID Numbers: B1691001
Study First Received: June 24, 2009
Last Updated: December 18, 2009
Health Authority: Singapore: Health Sciences Authority

ClinicalTrials.gov processed this record on November 20, 2014