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

Phase 1

Completed

• Conditions: Dyslipidemia
• Interventions: Drug: anacetrapib

• Registration Number: NCT01114490
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-29
• Study First Submitted QC: 2010-04-30
• Study Start: 2010-05
• Study First Posted: 2010-05-03
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-12
• Last Update Posted: 2015-10-14

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
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part 1 - Group 1	anacetrapib	Moderate Hepatic Patients
Part 1 - Group 2	anacetrapib	Healthy Subjects
Part 2 - Group 1	anacetrapib	Mild Hepatic Patients
Part 2 - Group 2	anacetrapib	Healthy 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
Tolerability of a single dose administration of 100mg anacetrapib, measured by the number of clinical and laboratory adverse events	through 14 days post dose