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Trial record 3 of 16 for:    anacetrapib

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE May 11, 2010
First Posted Date  ICMJE May 13, 2010
Last Update Posted Date August 14, 2015
Study Start Date  ICMJE June 2010
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2010)
Area Under the Curve (AUC(0 to infinity)) of anacetrapib [ Time Frame: through 168 hours post dose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2010)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics of Anacetrapib (MK0859) in Subjects With Impaired Renal Function (MK-0859-038)
Official Title  ICMJE A Single-Dose Study to Investigate the Pharmacokinetics of MK0859 in Subjects With Impaired Renal Function
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Dyslipidemia
Intervention  ICMJE Drug: anacetrapib
single dose administration of anacetrapib (MK0859) 100 mg oral tablet
Study Arms  ICMJE
  • Experimental: Part 1 - Panel A
    Subjects with severe renal impairment
    Intervention: Drug: anacetrapib
  • Experimental: Part 1 - Panel B
    Healthy matched control subjects
    Intervention: Drug: anacetrapib
  • Experimental: Part 2 - Panel C
    Subjects with moderate renal impairment
    Intervention: Drug: anacetrapib
  • Experimental: Part 2 - Panel D
    Healthy matched control subjects
    Intervention: Drug: anacetrapib
  • Experimental: Part 2 - Panel E
    Subjects with mild renal impairment
    Intervention: Drug: anacetrapib
  • Experimental: Part 2 - Panel F
    Healthy matched control subjects
    Intervention: Drug: anacetrapib
Publications * Lauring B, Li XS, Liu Y, Corr C, Lazarus N, Cote J, Larson P, Levonas AO, Lasseter KC, Preston RA, Smith WB, Lai E, Wagner JA. Influence of renal and hepatic impairment on the pharmacokinetics of anacetrapib. J Clin Pharmacol. 2014 Nov;54(11):1247-55. doi: 10.1002/jcph.320. Epub 2014 Jun 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 7, 2011)
24
Original Estimated Enrollment  ICMJE
 (submitted: May 11, 2010)
72
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01122667
Other Study ID Numbers  ICMJE 0859-038
MK0859-038
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP