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Completed

NCT Number: NCT01043887

Ridaforolimus in Patients With Hepatic Insufficiency (MK-8669-046)

This study will evaluate the pharmacokinetics of ridaforolimus including the area under the concentration-time curve (AUC[0-infinity]) and maximum concentration (Cmax) after administration of a single dose of ridaforolimus in patients with moderate hepatic insufficiency and healthy matched control subjects.

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Key information

Conditions

Healthy Volunteers Digestive System Diseases Hepatic Insufficiency Liver Diseases

Age range

18 year–75 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

Hepatic Patients:

  • Female patient is of non-child bearing potential
  • Apart from hepatic insufficiency with features of cirrhosis, patient is otherwise in good health
  • Patient has a diagnosis of chronic stable hepatic insufficiency with features of cirrhosis

Healthy Subjects:

  • Female subject is of non-childbearing potential
  • Subject is in good health

Exclusion criteria

Hepatic Patients and Healthy Subjects:

  • Works a night shift and is not able to avoid night shift work during the study
  • Has a history of stroke, seizure or major neurological disease
  • Has a history of cancer
  • Is unable to refrain from or anticipates the use of any prescription or non-prescription drugs during the study
  • Consumes excessive amounts of alcohol or caffeine
  • Has had major surgery, donated blood or participated in another investigational study in the past 4 weeks

Treatment and study plan

ridaforolimus

Drug

single oral dose administration 10 mg ridaforolimus

Primary outcomes

  1. Area Under the Curve (AUC[0-infinity]) of ridaforolimus following a single oral dose.

    Time frame: 288 hours postdose

  2. Maximum Concentration (Cmax) of ridaforolimus following a single oral dose.

    Time frame: 288 hours postdose

  3. Tmax of a Single Oral Dose of Ridaforolimus.

    Time frame: 288 hours postdose

  4. Apparent Terminal Half-life (t1/2) of a Single Oral Dose of Ridaforolimus.

    Time frame: 288 hours postdose

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

  • Ariad Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 7, 2010
Registry last updated
Apr 29, 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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