Pharmacokinetics of Anacetrapib (MK0859) in Patients With Hepatic Insufficiency (MK-0859-039)

Phase 1CompletedNCT01114490

Merck Sharp & Dohme LLC24 enrolled

Overview

This study will evaluate the Area Under the Curve (AUC(0 to infinity)) of anacetrapib.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dyslipidemia

Interventions

anacetrapibDRUG

single dose administration of anacetrapib (MK0859) 100 mg oral tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 * Subject agrees to refrain from consumption of red wine, grapefruit, orange and apple juices throughout the study Exclusion Criteria: * Patient has a history of cancer * Patient is a nursing mother * Patient is unable to refrain from or anticipates the use of any prescription or non-prescription medication during the study * Patient consumes excessive amounts of alcohol or caffeine * Patient has had major surgery, donated blood or participated in another investigational study within the past 4 weeks

Outcomes

Primary Outcomes

Area Under the Curve (AUC(0 to infinity)) of anacetrapib

Time frame: through 168 hours post dose

Secondary Outcomes

Tolerability of a single dose administration of 100mg anacetrapib, measured by the number of clinical and laboratory adverse events

Time frame: through 14 days post dose

Data from ClinicalTrials.gov

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