Drug-Drug Interaction Study Of Effect Of PF-03882845 On Simvastatin Pharmacokinetics

Pfizer

Status and phase

Completed

Phase 1

Conditions

Human Volunteers

Treatments

Drug: Simvastatin/PF-03882845

Study type

Interventional

Funder types

Industry

Identifiers

NCT01445860

B0171013

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.