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

• Sponsor: Merck Sharp & Dohme LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01043887
• Collaborator: Ariad Pharmaceuticals (Industry)
• Enrollment: 19
• Arms: 2
• Duration (Months): 3

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Healthy Volunteers; Hepatic Insufficiency	Drug: ridaforolimus	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Single Dose Study to Investigate the Pharmacokinetics of Ridaforolimus in Patients With Hepatic Insufficiency
• Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Apr 1, 2010
• Actual Study Completion Date: Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Area Under the Curve (AUC[0-infinity]) of ridaforolimus following a single oral dose. [288 hours postdose]

2. Maximum Concentration (Cmax) of ridaforolimus following a single oral dose. [288 hours postdose]

3. Tmax of a Single Oral Dose of Ridaforolimus. [288 hours postdose]

4. Apparent Terminal Half-life (t1/2) of a Single Oral Dose of Ridaforolimus. [288 hours postdose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

No locations specified.

Sponsors and Collaborators

• Merck Sharp & Dohme LLC
• Ariad Pharmaceuticals

Investigators

• Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Merck Sharp & Dohme LLC
• ClinicalTrials.gov Identifier: NCT01043887
• Other Study ID Numbers: 8669-046; MK8669-046; 2009_706
• First Posted: Jan 7, 2010
• Last Update Posted: Apr 29, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by Merck Sharp & Dohme LLC: Healthy Volunteers; Hepatic Insufficiency
• Additional relevant MeSH terms: Hepatic Insufficiency; Liver Failure

Study Results

No Results Posted as of Apr 29, 2015