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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-04-30

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.

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Detailed Description

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Conditions

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Healthy Volunteers Hepatic Insufficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

ridaforolimus

Intervention Type DRUG

single oral dose administration 10 mg ridaforolimus

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.

Group Type EXPERIMENTAL

ridaforolimus

Intervention Type DRUG

single oral dose administration 10 mg ridaforolimus

Interventions

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ridaforolimus

single oral dose administration 10 mg ridaforolimus

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes