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


Phase 1
18 Years
75 Years
Not Enrolling
Both
Sarcoma, Hepatic Insufficiency

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Trial Information

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


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:

- Patient works a night shift and is not able to avoid night shift work during the
study

- Patient has a history of stroke, seizure or major neurological disease

- Patient has a history of cancer

- Patient is unable to refrain from or anticipates the use of any prescription or
non-prescription drugs during the study

- Patient consumes excessive amounts of alcohol or caffeine

- Patient has had major surgery, donated blood or participated in another
investigational study in the past 4 weeks

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

AUC(0-infinity) of ridaforolimus following a single oral dose

Outcome Time Frame:

through 288 hours post dose

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Merck

Authority:

United States: Food and Drug Administration

Study ID:

2009_706

NCT ID:

NCT01043887

Start Date:

January 2010

Completion Date:

April 2010

Related Keywords:

  • Sarcoma
  • Hepatic Insufficiency
  • Sarcoma
  • Hepatic Insufficiency
  • Sarcoma
  • Hepatic Insufficiency

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