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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00928278
Recruitment Status : Completed
First Posted : June 25, 2009
Last Update Posted : December 21, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: Treatment A Drug: Treatment B Drug: Treatment C Drug: Treatment D Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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.
Study Start Date : July 2009
Primary Completion Date : October 2009
Study Completion Date : October 2009
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Plasma pharmacokinetic parameters: AUClast and Cmax [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. Plasma pharmacokinetic parameters: AUC0-12, AUC0-24, AUCinf, Tmax and terminal half-life. [ Time Frame: 48 hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00928278     History of Changes
Obsolete Identifiers: NCT00977535
Other Study ID Numbers: B1691001
First Posted: June 25, 2009    Key Record Dates
Last Update Posted: December 21, 2009
Last Verified: December 2009