Dyslipidemia
Conditions
Keywords
Renal Insufficiency
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.
Interventions
DRUGanacetrapib
single dose administration of anacetrapib (MK0859) 100 mg oral tablet
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Curve (AUC(0 to infinity)) of anacetrapib | through 168 hours post dose |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed