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

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ClinicalTrials.gov Identifier: NCT01122667
Recruitment Status : Completed
First Posted : May 13, 2010
Last Update Posted : August 14, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Dyslipidemia Drug: anacetrapib Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Dose Study to Investigate the Pharmacokinetics of MK0859 in Subjects With Impaired Renal Function
Study Start Date : June 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Area Under the Curve (AUC(0 to infinity)) of anacetrapib [ Time Frame: through 168 hours post dose ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01122667


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

Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01122667     History of Changes
Other Study ID Numbers: 0859-038
MK0859-038
First Posted: May 13, 2010    Key Record Dates
Last Update Posted: August 14, 2015
Last Verified: August 2015

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

Additional relevant MeSH terms:
Dyslipidemias
Renal Insufficiency
Lipid Metabolism Disorders
Metabolic Diseases
Kidney Diseases
Urologic Diseases
Anacetrapib
Oxazolidinones
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors