Healthy
Conditions
Keywords
Phase 1, relative bioavailability, healthy volunteers, pharmacokinetics, solution, tablet
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.
Interventions
DRUGPF-04634817
single dose, 20mg, tablet
Sponsors
Incyte Corporation
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed