Study To Determine The Effect Of Food And Strong CYP3A4 Enzyme Inhibitor On PF-04449913 Drug Levels
- Registration Number
- NCT01749085
- Lead Sponsor
- Pfizer
- Brief Summary
The study aims to determine what effect a high fat meal will have on the drug exposure of PF-04449913. The study also aims to determine the effect of a strong enzyme (CYP3A4) inhibitor on drug exposure of PF-04449913.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
Inclusion Criteria
- Healthy male and 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.
- 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.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion Criteria
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- A positive urine drug screen
- 12-lead ECG demonstrating QTc >450 msec or a QRS interval >120 msec at Screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTc values should be used to determine the subject's eligibility. Subjects with one of the following currently in the past 6 months: myocardial infarction, congenital long QT syndrome, torsades de pointes or clinically significant ventricular arrhythmias.
- Pregnant or nursing females and females of childbearing potential including those with tubal ligation. To be considered for enrollment, women of 45 to 55 years of age who are postmenopausal (defined as being amenorrheic for at least 2 years) must have confirmatory FSH test results at Screening.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence 1 PF-04449913, ketoconazole - Sequence 2 PF-04449913, ketoconazole -
- Primary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) 8 days Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] 8 days
- Secondary Outcome Measures
Name Time Method Plasma Decay Half-Life (t1/2) 8 days Time to Reach Maximum Observed Plasma Concentration (Tmax) 8 days Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) 8 days Apparent Oral Clearance (CL/F) 8 days Apparent Volume of Distribution (Vz/F) 8 days
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸New Haven, Connecticut, United States