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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Dyslipidemia

Treatments: Drug: anacetrapib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01114490

0859-039

2010_530

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

Part 1 - Group 1

Experimental group

Description:

Moderate Hepatic Patients

Treatment:

Drug: anacetrapib

Part 1 - Group 2

Experimental group

Description:

Healthy Subjects

Treatment:

Drug: anacetrapib

Part 2 - Group 1

Experimental group

Description:

Mild Hepatic Patients

Treatment:

Drug: anacetrapib

Part 2 - Group 2

Experimental group

Description:

Healthy Subjects

Treatment:

Drug: anacetrapib