Back to resultsA Study Estimating The Time Course Of PF-04764793 In The Blood Following Dosing By Oral Inhalation From Dry Powder Inhalers
Primary Purpose
Healthy
Status
Completed
Phase
Phase 1
Locations
Singapore
Study Type
Interventional
Intervention
Treatment A
Treatment B
Treatment C
Treatment D
Sponsored by
About this trial
This is an interventional basic science trial for Healthy
Eligibility 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.
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
Treatment A - PF-04764793
Treatment B - PF-04764793
Treatment C - PF-04764793
Treatment D - PF-04764793
Arm Description
PF-04764793 using inhaler A
PF-04764793 using inhaler B
PF-04764793 using inhaler A
PF-04764793 using inhaler B
Outcomes
Primary Outcome Measures
Plasma pharmacokinetic parameters: AUClast and Cmax
Secondary Outcome Measures
Plasma pharmacokinetic parameters: AUC0-12, AUC0-24, AUCinf, Tmax and terminal half-life.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00928278
Brief Title
A Study Estimating The Time Course Of PF-04764793 In The Blood Following Dosing By Oral Inhalation From Dry Powder Inhalers
Official Title
An Open Study To Estimate The Plasma Pharmacokinetics Of PF-04764793 Administered Via Oral Inhalation Using Dry Powder Inhalers.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment A - PF-04764793
Arm Type
Experimental
Arm Description
PF-04764793 using inhaler A
Arm Title
Treatment B - PF-04764793
Arm Type
Active Comparator
Arm Description
PF-04764793 using inhaler B
Arm Title
Treatment C - PF-04764793
Arm Type
Experimental
Arm Description
PF-04764793 using inhaler A
Arm Title
Treatment D - PF-04764793
Arm Type
Active Comparator
Arm Description
PF-04764793 using inhaler B
Intervention Type
Drug
Intervention Name(s)
Treatment A
Intervention Description
Inhaled, 300/150, single dose
Intervention Type
Drug
Intervention Name(s)
Treatment B
Intervention Description
Inhaled, 300/150, single dose
Intervention Type
Drug
Intervention Name(s)
Treatment C
Intervention Description
Inhaled, 300/150, single dose + oral activated charcoal block
Intervention Type
Drug
Intervention Name(s)
Treatment D
Intervention Description
Inhaled, 300/150, single dose + oral activated charcoal block
Primary Outcome Measure Information:
Title
Plasma pharmacokinetic parameters: AUClast and Cmax
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Plasma pharmacokinetic parameters: AUC0-12, AUC0-24, AUCinf, Tmax and terminal half-life.
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Singapore
ZIP/Postal Code
188770
Country
Singapore
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1691001&StudyName=A%20Study%20Estimating%20The%20Time%20Course%20Of%20PF-04764793%20In%20The%20Blood%20Following%20Dosing%20By%20Oral%20Inhalation%20From%20Dry%20Powder%20Inhalers
Description
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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
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