An Open Study To Estimate The Plasma Pharmacokinetics Of PF-04764793 Administered Via Oral Inhalation Using Dry Powder Inhalers
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Plasma pharmacokinetic parameter: Maximum concentration (Cmax) for PF-04764793 in plasma.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Treatment A PF-04764793
PF-04764793 using inhaler A
Intervention: Treatment A (Drug)
Treatment B PF-04764793
PF-04764793 using inhaler A
Intervention: Treatment B (Drug)
Treatment C PF-04764793
PF-04764793 using inhaler A
Intervention: Treatment C (Drug)
Treatment D PF-04764793
PF-04764793 using inhaler A
Intervention: Treatment D (Drug)
Treatment E PF-04764793
PF-04764793 using inhaler B
Intervention: Treatment E (Drug)
Treatment F PF-04764793
PF-04764793 using inhaler B
Intervention: Treatment F (Drug)
Treatment G PF-04764793
PF-04764793 using inhaler B
Intervention: Treatment G (Drug)
Outcomes
Primary Outcomes
Plasma pharmacokinetic parameter: Maximum concentration (Cmax) for PF-04764793 in plasma.
Time Frame: 48 hours
Plasma pharmacokinetic parameter: Area under the curve (AUClast)from the time of dosing to the last data point taken for PF-04764793
Time Frame: 48 hours
Secondary Outcomes
- Plasma pharmacokinetic parameter: Time of maximum (Tmax) concentration of PF-04764793 in plasma.(48 hours)
- 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: Terminal half-life of PF-04764793.(48 hours)