A Phase 1, Open Label, Randomized, Single Dose, Cross-Over Study To Evaluate The Effect Of Food On PF-04447943 Pharmacokinetics In Healthy Adult Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Pharmacokinetic endpoints include plasma PF-04447943 area under the curve (AUC), maximum plasma concentration (Cmax) and time of maximum plasma concentration (Tmax).
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Sequence 1
Intervention: PF-04447943 (Drug)
Sequence 2
Intervention: PF-04447943 (Drug)
Outcomes
Primary Outcomes
Pharmacokinetic endpoints include plasma PF-04447943 area under the curve (AUC), maximum plasma concentration (Cmax) and time of maximum plasma concentration (Tmax).
Time Frame: Up to 96 hours after drug administration
Safety endpoints include vital signs, ECGs, clinical laboratory tests, clinical evaluations and examinations, and adverse events.
Time Frame: Up to 96 hours after drug administration
Secondary Outcomes
- No secondary outcomes(No secondary outcomes)