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Completed

NCT Number: NCT01122667

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

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.

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Key information

Conditions

Dyslipidemia Dyslipidemias Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Lipid Metabolism Disorders Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anacetrapib

Drug

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

Primary outcomes

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

    Time frame: 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

    Time frame: through 14 days post dose

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 13, 2010
Registry last updated
Aug 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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