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

August 13, 2015 updated by: Merck Sharp & Dohme LLC

A Single-Dose Study to Investigate the Pharmacokinetics of MK0859 in Subjects With Impaired Renal Function

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area Under the Curve (AUC(0 to infinity)) of anacetrapib
Time Frame: through 168 hours post dose
through 168 hours post dose

Secondary Outcome Measures

Outcome Measure
Time Frame
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
through 14 days post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

May 11, 2010

First Submitted That Met QC Criteria

May 11, 2010

First Posted (Estimate)

May 13, 2010

Study Record Updates

Last Update Posted (Estimate)

August 14, 2015

Last Update Submitted That Met QC Criteria

August 13, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0859-038
  • MK0859-038

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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