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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01114490
First received: April 29, 2010
Last updated: March 1, 2012
Last verified: December 2010
  Purpose

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


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 Patients With Hepatic Insufficiency

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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:
  • 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: No ]

Enrollment: 24
Study Start Date: May 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1 - Group 1
Moderate Hepatic Patients
Drug: anacetrapib
single dose administration of anacetrapib (MK0859) 100 mg oral tablet
Experimental: Part 1 - Group 2
Healthy Subjects
Drug: anacetrapib
single dose administration of anacetrapib (MK0859) 100 mg oral tablet
Experimental: Part 2 - Group 1
Mild Hepatic Patients
Drug: anacetrapib
single dose administration of anacetrapib (MK0859) 100 mg oral tablet
Experimental: Part 2 - Group 2
Healthy 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01114490

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT01114490     History of Changes
Other Study ID Numbers: MK-0859-039, 2010_530
Study First Received: April 29, 2010
Last Updated: March 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Hepatic Insufficiency

Additional relevant MeSH terms:
Dyslipidemias
Hepatic Insufficiency
Lipid Metabolism Disorders
Metabolic Diseases
Liver Diseases
Digestive System Diseases
Anacetrapib
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014