Pharmacokinetics of Anacetrapib (MK0859) in Subjects With Impaired Renal Function (MK-0859-038)

Study Overview
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Brief Summary
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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.

Official Title
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A Single-Dose Study to Investigate the Pharmacokinetics of MK0859 in Subjects With Impaired Renal Function

Conditions
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Dyslipidemia

Intervention / Treatment
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* Drug: anacetrapib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1 - Panel A<br>Subjects with severe renal impairment | Drug: anacetrapib<br>* single dose administration of anacetrapib (MK0859) 100 mg oral tablet<br>|
| Experimental: Part 1 - Panel B<br>Healthy matched control subjects | Drug: anacetrapib<br>* single dose administration of anacetrapib (MK0859) 100 mg oral tablet<br>|
| Experimental: Part 2 - Panel C<br>Subjects with moderate renal impairment | Drug: anacetrapib<br>* single dose administration of anacetrapib (MK0859) 100 mg oral tablet<br>|
| Experimental: Part 2 - Panel D<br>Healthy matched control subjects | Drug: anacetrapib<br>* single dose administration of anacetrapib (MK0859) 100 mg oral tablet<br>|
| Experimental: Part 2 - Panel E<br>Subjects with mild renal impairment | Drug: anacetrapib<br>* single dose administration of anacetrapib (MK0859) 100 mg oral tablet<br>|
| Experimental: Part 2 - Panel F<br>Healthy matched control subjects | Drug: anacetrapib<br>* single dose administration of anacetrapib (MK0859) 100 mg oral tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve (AUC(0 to infinity)) of anacetrapib |  | through 168 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal Insufficiency