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

NCT01122667 | Completed Phase 1

• 2 other identifiers: 0859-038MK0859-038
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dyslipidemia

Keywords

Renal Insufficiency

Outcome Measures

Primary Outcomes (1)

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

  through 168 hours post dose

Secondary Outcomes (1)

• 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

Study Arms (6)

Part 1 - Panel A

EXPERIMENTAL

Subjects with severe renal impairment

Drug: anacetrapib

Part 1 - Panel B

EXPERIMENTAL

Healthy matched control subjects

Drug: anacetrapib

Part 2 - Panel C

EXPERIMENTAL

Subjects with moderate renal impairment

Drug: anacetrapib

Part 2 - Panel D

EXPERIMENTAL

Healthy matched control subjects

Drug: anacetrapib

Part 2 - Panel E

EXPERIMENTAL

Subjects with mild renal impairment

Drug: anacetrapib

Part 2 - Panel F

EXPERIMENTAL

Healthy matched control subjects

Drug: anacetrapib

Interventions

anacetrapib DRUG

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

Part 1 - Panel A; Part 1 - Panel B; Part 2 - Panel C; Part 2 - Panel D; Part 2 - Panel E; Part 2 - Panel F

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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
• If Subject is a smoker, smoking is limited to no more than 10 cigarettes per day

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

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: 24782116 RESULT

MeSH Terms

Conditions

Dyslipidemias; Renal Insufficiency

Interventions

anacetrapib

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

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: May 11, 2010
• First Posted: May 13, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: August 14, 2015

Record last verified: 2015-08