A Phase 1, Open-Label, Fixed-Sequence Study To Estimate The Effect Of Repeated Dosing Of PF-05175157 On The Pharmacokinetics Of A Single Dose Of Simvastatin In Healthy Adult Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Area under the plasma concentration curve of simvastatin and simvastatin acid
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Single arm, fixed sequence dosing
Intervention: PF-05175157 (Drug)
Single arm, fixed sequence dosing
Intervention: Simvastatin (Drug)
Outcomes
Primary Outcomes
Area under the plasma concentration curve of simvastatin and simvastatin acid
Time Frame: 10 days
If the data permit, area under the plasma concentration curve of simvastatin and simvastatin acid extrapolated to infinite time
Time Frame: 10 days
Maximum observed plasma concentration of simvastatin and simvastatin acid
Time Frame: 10 days
Time at which maximum plasma concentration of simvastatin and simvastatin acid is observed
Time Frame: 10 days
If the data permit, terminal elimination half-life of simvastatin and simvastatin acid
Time Frame: 10 days
Secondary Outcomes
No secondary outcomes reported