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

Primary Purpose

Dyslipidemia

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

anacetrapib

About this trial

This is an interventional treatment trial for Dyslipidemia focused on measuring Hepatic Insufficiency

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Part 1 - Group 1

Part 1 - Group 2

Part 2 - Group 1

Part 2 - Group 2

Arm Description

Moderate Hepatic Patients

Healthy Subjects

Mild Hepatic Patients

Healthy Subjects

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01114490

First Posted

April 29, 2010

Last Updated

October 12, 2015

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT01114490

Brief Title

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

Official Title

A Single Dose Study to Investigate the Pharmacokinetics of MK0859 in Patients With Hepatic Insufficiency

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

May 2010 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyslipidemia

Keywords

Hepatic Insufficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part 1 - Group 1

Arm Type

Experimental

Arm Description

Moderate Hepatic Patients

Arm Title

Part 1 - Group 2

Arm Type

Experimental

Arm Description

Healthy Subjects

Arm Title

Part 2 - Group 1

Arm Type

Experimental

Arm Description

Mild Hepatic Patients

Arm Title

Part 2 - Group 2

Arm Type

Experimental

Arm Description

Healthy Subjects

Intervention Type

Drug

Intervention Name(s)

anacetrapib

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

through 168 hours post dose

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

24782116

Citation

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.

Results Reference

result

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

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