Healthy
Conditions
Brief summary
This study aims to test plasma exposure to PF-05089771 with same formulation will be used for phase II trials (capsule).
Interventions
DRUGPF-05089771
450mg
Sponsors
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 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 measurement, 12-lead ECG and clinical laboratory tests). Females must be of non-childbearing potential. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). * An informed consent document signed and dated by the subject or a legally acceptable representative, indicating that the subject has been informed of all pertinent aspects of the trial. * Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures
Exclusion criteria
* Evidence or history of clinically significant hematological, renal (i.e recurrent uric nephrolithiasis), endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). * Any condition possibly affecting drug absorption (eg, gastrectomy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] | 48 hours |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | 48 hours |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Laboratory Test Values of Potential Clinical Importance | 48 hours |
Countries
Belgium
Outcome results
None listed