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| ID | Type | Description | Link |
|---|---|---|---|
| MK8669-046 | |||
| 2009_706 |
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| Name | Class |
|---|---|
| Ariad Pharmaceuticals | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ridaforolimus | Drug | single oral dose administration 10 mg ridaforolimus |
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| Measure | Description | 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 |
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Inclusion Criteria:
Hepatic Patients:
Healthy Subjects:
Exclusion Criteria:
Hepatic Patients and Healthy Subjects:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C515074 | ridaforolimus |
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