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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers; Hepatic Insufficiency

Treatments: Drug: ridaforolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT01043887

MK8669-046

2009_706

8669-046

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

Patients with Moderate Hepatic Insufficiency

Experimental group

Description:

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.

Treatment:

Drug: ridaforolimus

Healthy Control Subjects

Experimental group

Description:

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.

Treatment:

Drug: ridaforolimus