A Comparison Of A Single PF-04634817 Tablet Dose Compared With A Solution In Healthy Volunteers
- Registration Number
- NCT01247883
- Lead Sponsor
- Pfizer
- Brief Summary
This study investigates the safety, tolerability and pharmacokinetics of PF-04634817 when respectively given orally as a single tablet dose and a single dose of a solution.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
Inclusion Criteria
- Healthy male and/or female subjects (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history and full physical examination.)
- 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;
- Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication;
- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day;
- Nursing females;
- Females of childbearing potential.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description single dose PF-04634817 tablet PF-04634817 subjects receive a single dose of PF-04634817 as a tablet single dose PF-04634817 solution PF-04634817 subjects receive a single dose of PF-04634817 as a solution
- Primary Outcome Measures
Name Time Method adverse events 4 days Plasma Pharmacokinetics for both tablet and solution dosage forms. 4 days The relative bioavailability (Frel) of PF-04634817 when administered as a tablet compared with a solution. 4 days lab measurements 4 days vitals/ECG parameters 4 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸New Haven, Connecticut, United States