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

This study has been completed.
Sponsor:
Collaborator:
Ariad Pharmaceuticals
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01043887
First received: January 5, 2010
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
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

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Area Under the Curve (AUC[0-infinity]) of ridaforolimus following a single oral dose. [ Time Frame: 288 hours postdose ] [ Designated as safety issue: No ]
  • Maximum Concentration (Cmax) of ridaforolimus following a single oral dose. [ Time Frame: 288 hours postdose ] [ Designated as safety issue: No ]
  • Tmax of a Single Oral Dose of Ridaforolimus. [ Time Frame: 288 hours postdose ] [ Designated as safety issue: No ]
  • Apparent Terminal Half-life (t1/2) of a Single Oral Dose of Ridaforolimus. [ Time Frame: 288 hours postdose ] [ Designated as safety issue: No ]

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: Patients with Moderate Hepatic Insufficiency
Patients with moderate hepatic insufficiency (a score of 7 to 9 on the Child-Pugh's scale) received a single 10 mg dose of ridaforolimus.
Drug: ridaforolimus
single oral dose administration 10 mg ridaforolimus
Experimental: Healthy Control Subjects
Healthy control subjects were matched by race, age, gender, and body mass index (BMI) to the patients with moderate hepatic insufficiency. The healthy control subjects also received a single 10 mg dose of 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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Ariad Pharmaceuticals
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01043887     History of Changes
Other Study ID Numbers: 8669-046, MK8669-046, 2009_706
Study First Received: January 5, 2010
Last Updated: May 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Healthy Volunteers
Hepatic Insufficiency

Additional relevant MeSH terms:
Hepatic Insufficiency
Digestive System Diseases
Liver Diseases
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014