Clinical Trial: Ridaforolimus in Patients With Hepatic Insufficiency (MK-8669-046)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Single Dose Study to Investigate the Pharmacokinetics of Ridaforolimus in Patients With 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.
Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.
Current Primary Outcome:
- Area Under the Curve (AUC[0-infinity]) of ridaforolimus following a single oral dose. [ Time Frame: 288 hours postdose ]
- Maximum Concentration (Cmax) of ridaforolimus following a single oral dose. [ Time Frame: 288 hours postdose ]
- Tmax of a Single Oral Dose of Ridaforolimus. [ Time Frame: 288 hours postdose ]
- Apparent Terminal Half-life (t1/2) of a Single Oral Dose of Ridaforolimus. [ Time Frame: 288 hours postdose ]
Original Primary Outcome: AUC(0-infinity) of ridaforolimus following a single oral dose [ Time Frame: through 288 hours post dose ]
Current Secondary Outcome:
Original Secondary Outcome:
- Cmax of ridaforolimus [ Time Frame: through 288 hours post dose ]
- Tolerability of ridaforolimus measured by number of clinical and laboratory adverse experiences [ Time Frame: up to 14 days after last dose ]
Information By: Merck Sharp & Dohme Corp.
Dates:
Date Received: January 5, 2010
Date Started: January 2010
Date Completion:
Last Updated: April 28, 2015
Last Verified: April 2015
