A Phase 1 interventional study of ridaforolimus in Healthy Volunteers and Hepatic Insufficiency, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-29.
Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Treatment
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.
325 studies on the registry are indexed under Hepatic Insufficiency; 53 are open to participants now.
This study's enrollment of 19 is below the median of 36 across 220 interventional studies indexed under Hepatic Insufficiency.
Browse Hepatic Insufficiency studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Hepatic Patients:
Healthy Subjects:
Exclusion Criteria:
Hepatic Patients and Healthy Subjects:
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 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
single oral dose administration 10 mg ridaforolimus
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
No study locations are listed for this record.
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Merck Sharp & Dohme LLC