Text Size

Ridaforolimus in Patients With Hepatic Insufficiency (8669-046)

This study has been completed.
Sponsor:
Collaborator:
Ariad Pharmaceuticals
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT01043887
First received: January 5, 2010
Last updated: July 7, 2011
Last verified: July 2011
History of Changes
  Purpose

This study will evaluate the pharmacokinetics of ridaforolimus (AUC(0-infinity) and Cmax) after administration of a single dose of ridaforolimus in patients with moderate hepatic insufficiency and healthy matched control subjects.


Condition Intervention Phase
Sarcoma
Hepatic Insufficiency
 Drug: ridaforolimus
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Dose Study to Investigate the Pharmacokinetics of Ridaforolimus in Patients With Hepatic Insufficiency

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • AUC(0-infinity) of ridaforolimus following a single oral dose [ Time Frame: through 288 hours post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cmax of ridaforolimus [ Time Frame: through 288 hours post dose ] [ Designated as safety issue: No ]
  • Tolerability of ridaforolimus measured by number of clinical and laboratory adverse experiences [ Time Frame: up to 14 days after last dose ] [ Designated as safety issue: Yes ]

Enrollment: 19
Study Start Date: January 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hepatic Patients
10 mg ridaforolimus
 Drug: ridaforolimus
single oral dose administration 10 mg ridaforolimus
Experimental: Healthy Subjects
10 mg ridaforolimus
 Drug: ridaforolimus
single oral dose administration 10 mg ridaforolimus

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01043887

Sponsors and Collaborators
Merck
Ariad Pharmaceuticals
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT01043887     History of Changes
Other Study ID Numbers: 2009_706, MK8669-046
Study First Received: January 5, 2010
Last Updated: July 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck:
Sarcoma
Hepatic Insufficiency

Additional relevant MeSH terms:
Sarcoma
Hepatic Insufficiency
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Liver Diseases
Digestive System Diseases
Sirolimus
Antibiotics, Antineoplastic
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on June 18, 2013