A Study To Evaluate Whether Food Affects The Plasma Drug Levels Of A 35 mg Single Dose Of PF-04447943 Taken Orally In Healthy Adult Participants
- Registration Number
- NCT00886093
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of the study is to compare the plasma drug levels of PF-04447943 when taken as a 35 mg tablet after a high fat meal compared to when taken after fasting. Healthy adult volunteers will receive a single dose of the drug once when fasted and again when fed. The safety and tolerability of the drug will be monitored.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
- Healthy male and/or female subjects, not of child bearing potential.
- Age 18-55 inclusive
- Total body weight >50 kg.
Exclusion Criteria
- Evidence or history of clinical significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic diseases
- History of orthostatic blood pressure changes or orthostatic symptoms
- Greater than 7 drinks of alcohol per week for women and greater than 14 drinks per week for men
- Smoking more than 5 cigarettes per day
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence 2 PF-04447943 - Sequence 1 PF-04447943 -
- Primary Outcome Measures
Name Time Method Pharmacokinetic endpoints include plasma PF-04447943 area under the curve (AUC), maximum plasma concentration (Cmax) and time of maximum plasma concentration (Tmax). Up to 96 hours after drug administration Safety endpoints include vital signs, ECGs, clinical laboratory tests, clinical evaluations and examinations, and adverse events. Up to 96 hours after drug administration
- Secondary Outcome Measures
Name Time Method No secondary outcomes No secondary outcomes
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸New Haven, Connecticut, United States