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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01122667
First received: May 11, 2010
Last updated: July 7, 2011
Last verified: July 2011
  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

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:
  • 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 Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  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 Sharp & Dohme Corp.:
Renal Insufficiency

Additional relevant MeSH terms:
Renal Insufficiency
Dyslipidemias
Kidney Diseases
Urologic Diseases
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 21, 2014