Pharmacokinetics of Anacetrapib (MK0859) in Patients With Hepatic Insufficiency (MK-0859-039)
A Single Dose Study to Investigate the Pharmacokinetics of MK0859 in Patients With Hepatic Insufficiency
2 other identifiers
interventional
24
0 countries
N/A
Brief Summary
This study will evaluate the Area Under the Curve (AUC(0 to infinity)) of anacetrapib.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2010
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2010
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedFirst Posted
Study publicly available on registry
May 3, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedOctober 14, 2015
October 1, 2015
2 months
April 29, 2010
October 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Area Under the Curve (AUC(0 to infinity)) of anacetrapib
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
through 14 days post dose
Study Arms (4)
Part 1 - Group 1
EXPERIMENTALModerate Hepatic Patients
Part 1 - Group 2
EXPERIMENTALHealthy Subjects
Part 2 - Group 1
EXPERIMENTALMild Hepatic Patients
Part 2 - Group 2
EXPERIMENTALHealthy Subjects
Interventions
single dose administration of anacetrapib (MK0859) 100 mg oral tablet
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 24782116RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2010
First Posted
May 3, 2010
Study Start
May 1, 2010
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
October 14, 2015
Record last verified: 2015-10