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

NCT ID: NCT01114490

Last Updated: 2015-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2010-07-31

Brief Summary

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

Conditions

Dyslipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1 - Group 1

Moderate Hepatic Patients

Group Type: EXPERIMENTAL

anacetrapib

Intervention Type: DRUG

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

Part 1 - Group 2

Healthy Subjects

Group Type: EXPERIMENTAL

anacetrapib

Intervention Type: DRUG

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

Part 2 - Group 1

Mild Hepatic Patients

Group Type: EXPERIMENTAL

anacetrapib

Intervention Type: DRUG

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

Part 2 - Group 2

Healthy Subjects

Group Type: EXPERIMENTAL

anacetrapib

Intervention Type: DRUG

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

Interventions

anacetrapib

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Lauring B, Li XS, Liu Y, Corr C, Lazarus N, Cote J, Larson P, Levonas AO, Lasseter KC, Preston RA, Smith WB, Lai E, Wagner JA. Influence of renal and hepatic impairment on the pharmacokinetics of anacetrapib. J Clin Pharmacol. 2014 Nov;54(11):1247-55. doi: 10.1002/jcph.320. Epub 2014 Jun 6.

Reference Type: RESULT

PMID: 24782116 (View on PubMed)

Other Identifiers

2010_530

Identifier Type: -

Identifier Source: secondary_id

0859-039

Identifier Type: -

Identifier Source: org_study_id