This Study Is To Estimate The Time Course Of Pf-04764793 In The Blood Following Dosing By Oral Inhalation From Dry Powder Inhalers
An Open Study To Estimate The Plasma Pharmacokinetics Of PF-04764793 Administered Via Oral Inhalation Using Dry Powder Inhalers
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Jan 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 6, 2011
CompletedFirst Posted
Study publicly available on registry
January 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedDecember 3, 2018
November 1, 2018
4 months
January 6, 2011
November 29, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Plasma pharmacokinetic parameter: Area under the curve (AUClast)from the time of dosing to the last data point taken for PF-04764793
48 hours
Plasma pharmacokinetic parameter: Maximum concentration (Cmax) for PF-04764793 in plasma.
48 hours
Secondary Outcomes (4)
Plasma pharmacokinetic parameter: Area under the curve (AUC0-24) from time of dosing to 24 hours post dose for PF-04764793.
48 hours
Plasma pharmacokinetic parameter: Area under the curve (AUCinf) from the time of dosing extrapolated to infinity for PF-04764793.
48 hours
Plasma pharmacokinetic parameter: Time of maximum (Tmax) concentration of PF-04764793 in plasma.
48 hours
Plasma pharmacokinetic parameter: Terminal half-life of PF-04764793.
48 hours
Study Arms (7)
Treatment A PF-04764793
EXPERIMENTALPF-04764793 using inhaler A
Treatment B PF-04764793
EXPERIMENTALPF-04764793 using inhaler A
Treatment C PF-04764793
EXPERIMENTALPF-04764793 using inhaler A
Treatment D PF-04764793
EXPERIMENTALPF-04764793 using inhaler A
Treatment E PF-04764793
EXPERIMENTALPF-04764793 using inhaler B
Treatment F PF-04764793
EXPERIMENTALPF-04764793 using inhaler B
Treatment G PF-04764793
EXPERIMENTALPF-04764793 using inhaler B
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
Singapore, 188770, Singapore
Related Links
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 6, 2011
First Posted
January 7, 2011
Study Start
January 1, 2011
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
December 3, 2018
Record last verified: 2018-11