A Study To Estimate The Effect Of Repeated Dosing of PF-05175157 On The Pharmacokinetics Of A Single Dose Of Simvastatin In Healthy Adult Subjects
- Registration Number
- NCT01469468
- Lead Sponsor
- Pfizer
- Brief Summary
The study is designed to investigate the effect of repeated dosing of PF-05175157 on the pharmacokinetics of a single dose of Simvastatin in healthy adult subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
Inclusion Criteria
- Healthy subjects with normal results in all screening examinations.
- Body Mass Index of 17.5 to 35.5 kg/m2
Exclusion Criteria
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, ocular, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Known history of intolerance to simvastatin or other statins.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single arm, fixed sequence dosing Simvastatin - Single arm, fixed sequence dosing PF-05175157 -
- Primary Outcome Measures
Name Time Method Area under the plasma concentration curve of simvastatin and simvastatin acid 10 days If the data permit, area under the plasma concentration curve of simvastatin and simvastatin acid extrapolated to infinite time 10 days Maximum observed plasma concentration of simvastatin and simvastatin acid 10 days If the data permit, terminal elimination half-life of simvastatin and simvastatin acid 10 days Time at which maximum plasma concentration of simvastatin and simvastatin acid is observed 10 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸South Miami, Florida, United States