A Pharmacokinetic Study of Three Different Particle Sizes of PH-797804
- Registration Number
- NCT01924650
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to investigate the effects of varying particle size on the pharmacokinetics of PH-797804
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Healthy male subjects and/or healthy female subjects of non-child bearing potential between the ages of 18 and 55 years (inclusive). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12-lead ECG and clinical laboratory tests.
- 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).
- A positive urine drug screen.
- History of regular alcohol consumption exceeding 14 drinks/week for males.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description PH-797804 PARTICLE SIZE 9-11UM PH-797804 - PH-797804 PARTICLE SIZE 9-11UM WITH SLS PH-797804 - PH-797804 PARTICLE SIZE <= 20UM WITH SLS PH-797804 - PH-797804 PARTICLE SIZE <= 5UM PH-797804 - PH-797804 PARTICLE SIZE <= 5UM WITH SLS PH-797804 - PH-797804 PARTICLE SIZE <= 20UM PH-797804 -
- Primary Outcome Measures
Name Time Method Time to Reach Maximum Observed Plasma Concentration (Tmax) 0,2,3,4,5,6,8,12,24,48,72 hours post-dose Area Under the Curve From Time Zero to Time 72 hours (AUC72) 0,2,3,4,5,6,8,12,24,48,72 hours post-dose Area under the plasma concentration time-curve from zero to 72 hours (AUC72)
Maximum Observed Plasma Concentration (Cmax) 0,2,3,4,5,6,8,12,24,48,72 hours post-dose
- Secondary Outcome Measures
Name Time Method