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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy Volunteers, Hepatic Insufficiency

Intervention / Treatment
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* Drug: ridaforolimus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with Moderate Hepatic Insufficiency<br>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<br>* single oral dose administration 10 mg ridaforolimus<br>|
| Experimental: Healthy Control Subjects<br>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<br>* single oral dose administration 10 mg ridaforolimus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Volunteers, Hepatic Insufficiency