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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01043887
• Other study ID #: 8669-046
• Secondary ID: MK8669-0462009_7
• Status: Completed
• Phase: Phase 1
• First received: January 5, 2010
• Last updated: April 28, 2015
• Start date: January 2010
• Est. completion date: April 2010

Study information

• Verified date: April 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers
• Hepatic Insufficiency

Intervention

Drug:
• ridaforolimus
single oral dose administration 10 mg ridaforolimus

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.	Ariad Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve (AUC[0-infinity]) of ridaforolimus following a single oral dose.		288 hours postdose	No
Primary	Maximum Concentration (Cmax) of ridaforolimus following a single oral dose.		288 hours postdose	No
Primary	Tmax of a Single Oral Dose of Ridaforolimus.		288 hours postdose	No
Primary	Apparent Terminal Half-life (t1/2) of a Single Oral Dose of Ridaforolimus.		288 hours postdose	No