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Trial record 1 of 1 for:    NCT01181700
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A Study To Estimate The Time Course Of PF-00241939 Concentration In The Blood After Dosing With 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: NCT01181700
Recruitment Status : Completed
First Posted : August 13, 2010
Last Update Posted : January 24, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE August 11, 2010
First Posted Date  ICMJE August 13, 2010
Last Update Posted Date January 24, 2011
Study Start Date  ICMJE October 2010
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2010)
Plasma pharmacokinetic parameters: AUClast and Cmax. [ Time Frame: 36 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2010)
Plasma pharmacokinetic parameters: AUC24, AUCinf, Tmax and half-life. [ Time Frame: 36 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study To Estimate The Time Course Of PF-00241939 Concentration In The Blood After Dosing With Oral Inhalation From Dry Powder Inhalers
Official Title  ICMJE An Open Study To Estimate The Plasma Pharmacokinetics Of PF-00241939 Administered Via Oral Inhalation Using Dry Powder Inhalers
Brief Summary The purpose of this study is to investigate the time course of PF-00241939 concentrations in the blood following dosing by oral inhalation using dry powder inhalers.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Pharmacokinetics
Intervention  ICMJE
  • Drug: Treatment A
    PF-00241939 300 ug using inhaler A
  • Drug: Treatment B
    PF-00241939 300 ug using inhaler A
  • Drug: Treatment C
    PF-00241939 300 ug using inhaler A
  • Drug: Treatment D
    PF-00241939 300 ug using inhaler B
  • Drug: Treatment E
    PF-00241939 300 ug using inhaler B
  • Drug: Treatment F
    PF-00241939 300 ug using inhaler B
  • Drug: Treatment G
    PF-00241939 300 ug using inhaler B
Study Arms  ICMJE
  • Experimental: Treatment A
    Intervention: Drug: Treatment A
  • Experimental: Treatment B
    Intervention: Drug: Treatment B
  • Experimental: Treatment C
    Intervention: Drug: Treatment C
  • Active Comparator: Treatment D
    Intervention: Drug: Treatment D
  • Active Comparator: Treatment E
    Intervention: Drug: Treatment E
  • Active Comparator: Treatment F
    Intervention: Drug: Treatment F
  • Active Comparator: Treatment G
    Intervention: Drug: Treatment G
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 11, 2010)
42
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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/m2; 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).
  • Pregnant or nursing females.
  • A positive urine drug screen.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01181700
Other Study ID Numbers  ICMJE B0871015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP