Drug-Drug Interaction Study Of Effect Of PF-03882845 On Simvastatin Pharmacokinetics
Phase 1
Completed
- Conditions
- Human Volunteers
- Interventions
- Drug: Simvastatin/PF-03882845
- Registration Number
- NCT01445860
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to estimate the effect of multiple oral doses of PF-03882845 on the pharmacokinetics of simvastatin and simvastatin acid in healthy, adult subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
Inclusion Criteria
- Healthy males and/or females of non-childbearing potential between the ages of 18 (or 21 based on country-specific age of consent) and 60 years, inclusive, at Screening. 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 or clinical/safety laboratory tests.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 inclusive; and a total body weight >50 kg (110 lbs).
Exclusion Criteria
- Use of CYP3A4 inhibitors (eg, ketoconazole, ciprofloxacin, diltiazem) or inducers (eg, pheytoin, carbamazepine) or substrate (eg, simvastatin, quinidine) within 28 days or 5 half-lives (whichever is longer) prior to Day 1.
- Known history of hypersensitivity, allergy, severe adverse drug reaction or intolerance to simvastatin or other statins.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Simvastatin/PF-03882845 -
- Primary Outcome Measures
Name Time Method Composite (or Profile) of Pharmacokinetics 15 days AUCinf, AUClast, Cmax, Tmax, t1/2 of simvastatin and simvastatin acid
- Secondary Outcome Measures
Name Time Method Number of patients with adverse events as a measure of safety. 15 days
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇸🇬Singapore, Singapore