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

Dyslipidemia Clinical Trial

Official title:

A Single Dose Study to Investigate the Pharmacokinetics of MK0859 in Patients With Hepatic Insufficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01114490
• Other study ID #: 0859-039
• Secondary ID: 2010_530
• Status: Completed
• Phase: Phase 1
• First received: April 29, 2010
• Last updated: October 12, 2015
• Start date: May 2010
• Est. completion date: July 2010

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Hepatic Insufficiency

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve (AUC(0 to infinity)) of anacetrapib		through 168 hours post dose	No
Secondary	Tolerability of a single dose administration of 100mg anacetrapib, measured by the number of clinical and laboratory adverse events		through 14 days post dose	No