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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01043887

Enrollment

Registered

2010-01-07

Start date

2010-01-31

Completion date

2010-04-30

Last updated

2015-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers, Hepatic Insufficiency

Keywords

Healthy Volunteers, Hepatic Insufficiency

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.

Interventions

DRUGridaforolimus

single oral dose administration 10 mg ridaforolimus

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026