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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT01114490
First received: April 29, 2010
Last updated: March 1, 2012
Last verified: December 2010
History of Changes
  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

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

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  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:
Hepatic Insufficiency

Additional relevant MeSH terms:
Dyslipidemias
Hepatic Insufficiency
Lipid Metabolism Disorders
 Metabolic Diseases
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2013