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Completed

NCT Number: NCT01114490

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

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

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Key information

Conditions

Dyslipidemia Digestive System Diseases Dyslipidemias Hepatic Insufficiency Lipid Metabolism Disorders Liver Diseases Metabolic Diseases Nutritional and Metabolic 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
  • 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

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. 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 Patients With Hepatic Insufficiency

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 3, 2010
Registry last updated
Oct 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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