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

Purpose

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.

Condition	Intervention	Phase
Dyslipidemia	Drug: anacetrapib	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Single-Dose Study to Investigate the Pharmacokinetics of MK0859 in Subjects With Impaired Renal Function

Further study details as provided by Merck:

Primary Outcome Measures:

Area Under the Curve (AUC(0 to infinity)) of anacetrapib [ Time Frame: through 168 hours post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and 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 ] [ Designated as safety issue: Yes ]

Enrollment:	24
Study Start Date:	June 2010
Study Completion Date:	June 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Part 1 - Panel A Subjects with severe renal impairment	Drug: anacetrapib single dose administration of anacetrapib (MK0859) 100 mg oral tablet
Experimental: Part 1 - Panel B Healthy matched control subjects	Drug: anacetrapib single dose administration of anacetrapib (MK0859) 100 mg oral tablet
Experimental: Part 2 - Panel C Subjects with moderate renal impairment	Drug: anacetrapib single dose administration of anacetrapib (MK0859) 100 mg oral tablet
Experimental: Part 2 - Panel D Healthy matched control subjects	Drug: anacetrapib single dose administration of anacetrapib (MK0859) 100 mg oral tablet
Experimental: Part 2 - Panel E Subjects with mild renal impairment	Drug: anacetrapib single dose administration of anacetrapib (MK0859) 100 mg oral tablet
Experimental: Part 2 - Panel F Healthy matched control subjects	Drug: anacetrapib single dose administration of anacetrapib (MK0859) 100 mg oral tablet

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01122667

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Vice President, Late State Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT01122667 History of Changes
Other Study ID Numbers:	2010_536, MK0859-038
Study First Received:	May 11, 2010
Last Updated:	July 7, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Renal Insufficiency

Additional relevant MeSH terms:

Dyslipidemias
Renal Insufficiency
Lipid Metabolism Disorders

Metabolic Diseases
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013