Healthy Volunteers
Conditions
Keywords
PF-04449913, Food Effect, Drug-drug interaction, CYP3A4 inhibitor, Pharmacokinetics
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.
Interventions
DRUGPF-04449913, ketoconazole
Subjects receive a 200 mg oral dose of PF-04449913 under fasted conditions with washout, then single 200 mg oral dose of PF-04449913 under fed with washout and finally a single 200 mg dose 0f PF-04449913 following dosing to steady state with ketoconazole
Sponsors
Pfizer
Study design
Allocation
NON_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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Observed Plasma Concentration (Cmax) | 8 days |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] | 8 days |
Secondary
| Measure | Time frame |
|---|---|
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | 8 days |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 8 days |
| Plasma Decay Half-Life (t1/2) | 8 days |
| Apparent Volume of Distribution (Vz/F) | 8 days |
| Apparent Oral Clearance (CL/F) | 8 days |
Countries
United States
Outcome results
None listed