Status:
COMPLETED
Drug-Drug Interaction Study Of Effect Of PF-03882845 On Simvastatin Pharmacokinetics
Lead Sponsor:
Pfizer
Conditions:
Human Volunteers
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01445860
Start Date
August 1 2011
End Date
September 1 2011
Last Update
October 4 2011
Active Locations (1)
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1
Pfizer Investigational Site
Singapore, Singapore, 188770