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

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatic Insufficiency; Healthy Volunteers
• Intervention / Treatment: Drug: ridaforolimus

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area Under the Curve (AUC[0-infinity]) of ridaforolimus following a single oral dose.	288 hours postdose
Maximum Concentration (Cmax) of ridaforolimus following a single oral dose.	288 hours postdose
Tmax of a Single Oral Dose of Ridaforolimus.	288 hours postdose
Apparent Terminal Half-life (t1/2) of a Single Oral Dose of Ridaforolimus.	288 hours postdose

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Collaborators: Ariad Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: January 5, 2010
• First Submitted That Met QC Criteria: January 6, 2010
• First Posted (Estimate): January 7, 2010

Study Record Updates

• Last Update Posted (Estimate): April 29, 2015
• Last Update Submitted That Met QC Criteria: April 28, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Healthy Volunteers; Hepatic Insufficiency
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Liver Failure; Hepatic Insufficiency
• Other Study ID Numbers: 8669-046; MK8669-046; 2009_706