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CompletedNCT01114490Updated Oct 14, 2015

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

A Phase 1 interventional study of anacetrapib in Dyslipidemia, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-14.

Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Dyslipidemia

Keywords

  • Hepatic Insufficiency
03

In context

Hepatic Insufficiency

325 studies on the registry are indexed under Hepatic Insufficiency; 53 are open to participants now.

This study's enrollment of 24 is below the median of 36 across 220 interventional studies indexed under Hepatic Insufficiency.

Browse Hepatic Insufficiency studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Part 1 - Group 1

    Moderate Hepatic Patients

    Drug: anacetrapib

  • Experimental
    Part 1 - Group 2

    Healthy Subjects

    Drug: anacetrapib

  • Experimental
    Part 2 - Group 1

    Mild Hepatic Patients

    Drug: anacetrapib

  • Experimental
    Part 2 - Group 2

    Healthy Subjects

    Drug: anacetrapib

Interventions

  • Druganacetrapib

    single dose administration of anacetrapib (MK0859) 100 mg oral tablet

06

What researchers measure

Primary outcomes

  1. Area Under the Curve (AUC(0 to infinity)) of anacetrapib

    Time frame: through 168 hours post dose

Secondary outcomes

  1. 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

07

Study locations

No study locations are listed for this record.

08

References and documents

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. PubMed 24782116 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01114490
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
May 3, 2010
Start date
May 2010
Primary completion
Jul 2010
Completion
Jul 2010
Last update
Oct 14, 2015

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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