Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01512693 | Assessment of Pharmacokinetics of Single Dose Odanacatib (MK-0822) in Participants With Moderate Hepatic Insufficiency (MK-0822-070) | PHASE1 | COMPLETED | 17 | — | — | Feb 23, 2012 | Apr 24, 2012 | Aug 29, 2018 | - | — |
For healthy and moderate hepatic insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of AUC0-∞ (Total AUC). AUC0-∞ is a measure of total drug exposure.
| Arm | Type | Description |
|---|---|---|
| Moderate Hepatic Insufficiency Group | EXPERIMENTAL | Single-dose administration of odanacatib 50 mg to participants with moderate hepatic insufficiency. |
| Healthy Matched Control Group | EXPERIMENTAL | Single-dose administration of odanacatib 50 mg to healthy matched control participants. |
| Name | Type | Description |
|---|---|---|
| MK-0822 | DRUG | A single oral dose (50 mg tablet) of MK 0822 will be administered on Day 1 after an overnight fast. |
Inclusion Criteria: * Not currently pregnant, nursing or planning to be pregnant through-out the course of the study; agree to use specified contraception per protocol requirement * Body Mass Index (BMI) of ≤ 39 kg/m\^2 (not obese) * Judged to be in good health (for healthy participant population) ...