Pharmacokinetics of Anacetrapib (MK0859) in Subjects With Impaired Renal Function (MK-0859-038)
- Registration Number
- NCT01122667
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
This study will evaluate the Area Under the Curve (AUC(0 to infinity)) of anacetrapib in subjects with impaired renal function and healthy matched control subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- Female subjects of reproductive potential test negative for pregnancy and agree to use two acceptable methods of birth control throughout the study
- Subject is in good health
- If Subject is a smoker, smoking is limited to no more than 10 cigarettes per day
Exclusion Criteria
- Subject has a history of stroke, chronic seizures or major neurological disorder
- Subject has a history of cancer
- Subject is unable to refrain from or anticipates the use of any prescription or non-prescription medication during the study
- Subject consumes excessive amounts of alcohol or caffeine
- Subject has had major surgery, donated blood or participated in another investigational study within the past 4 weeks
- Subject is a nursing mother
- Subject has had a kidney removed or has a functioning renal transplant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1 - Panel A anacetrapib Subjects with severe renal impairment Part 2 - Panel C anacetrapib Subjects with moderate renal impairment Part 2 - Panel D anacetrapib Healthy matched control subjects Part 2 - Panel E anacetrapib Subjects with mild renal impairment Part 2 - Panel F anacetrapib Healthy matched control subjects Part 1 - Panel B anacetrapib Healthy matched control subjects
- Primary Outcome Measures
Name Time Method Area Under the Curve (AUC(0 to infinity)) of anacetrapib through 168 hours post dose
- Secondary Outcome Measures
Name Time Method Safety and tolerability of a single dose administration of 100mg anacetrapib, measured by the number of clinical and laboratory adverse events through 14 days post dose