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Pharmacokinetics of Anacetrapib (MK0859) in Subjects With Impaired Renal Function (MK-0859-038)

NCT ID: NCT01122667

Last Updated: 2015-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-06-30

Brief Summary

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This study will evaluate the Area Under the Curve (AUC(0 to infinity)) of anacetrapib in subjects with impaired renal function and healthy matched control subjects.

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Detailed Description

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Conditions

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Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1 - Panel A

Subjects with severe renal impairment

Group Type EXPERIMENTAL

anacetrapib

Intervention Type DRUG

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

Part 1 - Panel B

Healthy matched control subjects

Group Type EXPERIMENTAL

anacetrapib

Intervention Type DRUG

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

Part 2 - Panel C

Subjects with moderate renal impairment

Group Type EXPERIMENTAL

anacetrapib

Intervention Type DRUG

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

Part 2 - Panel D

Healthy matched control subjects

Group Type EXPERIMENTAL

anacetrapib

Intervention Type DRUG

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

Part 2 - Panel E

Subjects with mild renal impairment

Group Type EXPERIMENTAL

anacetrapib

Intervention Type DRUG

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

Part 2 - Panel F

Healthy matched control subjects

Group Type EXPERIMENTAL

anacetrapib

Intervention Type DRUG

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

Interventions

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anacetrapib

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

Intervention Type DRUG

Eligibility Criteria

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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
* If Subject is a smoker, smoking is limited to no more than 10 cigarettes per day

Exclusion Criteria

* Subject has a history of stroke, chronic seizures or major neurological disorder
* Subject has a history of cancer
* Subject is unable to refrain from or anticipates the use of any prescription or non-prescription medication during the study
* Subject consumes excessive amounts of alcohol or caffeine
* Subject has had major surgery, donated blood or participated in another investigational study within the past 4 weeks
* Subject is a nursing mother
* Subject has had a kidney removed or has a functioning renal transplant
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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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

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MK0859-038

Identifier Type: -

Identifier Source: secondary_id

0859-038

Identifier Type: -

Identifier Source: org_study_id

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