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

Phase 1

Completed

• Conditions: Healthy Volunteers; Hepatic Insufficiency
• Interventions: Drug: ridaforolimus

• Registration Number: NCT01043887
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-05
• Study First Submitted QC: 2010-01-06
• Study First Posted: 2010-01-07
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-28
• Last Update Posted: 2015-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Control Subjects	ridaforolimus	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.
Patients with Moderate Hepatic Insufficiency	ridaforolimus	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.

Primary Outcome Measures

Name	Time	Method
Area Under the Curve (AUC[0-infinity]) of ridaforolimus following a single oral dose.	288 hours postdose
Apparent Terminal Half-life (t1/2) of a Single Oral Dose of Ridaforolimus.	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