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

NCT01043887 | Completed Phase 1

• 3 other identifiers: 8669-046MK8669-0462009_706
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy Volunteers; Hepatic Insufficiency

Keywords

Healthy Volunteers; Hepatic Insufficiency

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Patients with Moderate Hepatic Insufficiency

EXPERIMENTAL

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

Healthy Control Subjects

EXPERIMENTAL

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

Interventions

ridaforolimus DRUG

single oral dose administration 10 mg ridaforolimus

Healthy Control Subjects; Patients with Moderate Hepatic Insufficiency

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Ariad Pharmaceuticals: collaborator

MeSH Terms

Conditions

Hepatic Insufficiency

Interventions

ridaforolimus

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2010
• First Posted: January 7, 2010
• Study Start: January 1, 2010
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: April 29, 2015

Record last verified: 2015-04