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

Dyslipidemia Clinical Trial

Official title:

A Single-Dose Study to Investigate the Pharmacokinetics of MK0859 in Subjects With Impaired Renal Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01122667
• Other study ID #: 0859-038
• Secondary ID: MK0859-038
• Status: Completed
• Phase: Phase 1
• First received: May 11, 2010
• Last updated: August 13, 2015
• Start date: June 2010
• Est. completion date: June 2011

Study information

• Verified date: August 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 in subjects with impaired renal function and healthy matched control subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• 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

• 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

Study Design

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

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Renal 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	Safety and tolerability of a single dose administration of 100mg anacetrapib, measured by the number of clinical and laboratory adverse events		through 14 days post dose	Yes