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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Dyslipidemia

Treatments: Drug: anacetrapib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01122667

0859-038

MK0859-038

Details and patient eligibility

About

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.

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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 6 patient groups

Part 1 - Panel A

Experimental group

Description:

Subjects with severe renal impairment

Treatment:

Drug: anacetrapib

Part 1 - Panel B

Experimental group

Description:

Healthy matched control subjects

Treatment:

Drug: anacetrapib

Part 2 - Panel C

Experimental group

Description:

Subjects with moderate renal impairment

Treatment:

Drug: anacetrapib

Part 2 - Panel D

Experimental group

Description:

Healthy matched control subjects

Treatment:

Drug: anacetrapib

Part 2 - Panel E

Experimental group

Description:

Subjects with mild renal impairment

Treatment:

Drug: anacetrapib

Part 2 - Panel F

Experimental group

Description:

Healthy matched control subjects

Treatment:

Drug: anacetrapib