Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-0822 · 2 trials · 2 indications
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. |
| Severe Renal Insufficiency Group | EXPERIMENTAL | Single-dose administration of odanacatib 50 mg to participants with severe renal insufficiency. |
| 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) ...
MK-0822, also known as odanacatib, is an investigational small molecule being studied for renal insufficiency and hepatic insufficiency. It is in Phase 1 clinical development by Merck & Company, Inc. (MRK). The drug is not approved and remains under clinical investigation.
MK-0822 is being developed by Merck & Company, Inc., which trades under the ticker MRK. The drug is currently in Phase 1 clinical trials for renal insufficiency and hepatic insufficiency.
MK-0822 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are being conducted to assess its pharmacokinetics in patients with renal or hepatic insufficiency.
MK-0822 has one completed Phase 1 trial, NCT01512667, which assessed single-dose pharmacokinetics in subjects with severe renal insufficiency. Another completed trial, NCT01512693, evaluated pharmacokinetics in participants with moderate hepatic insufficiency. Both trials are completed.
Yes, MK-0822 is also known as odanacatib. The drug is being studied under both names in clinical trials, including NCT01512667 and NCT01512693, which evaluate its pharmacokinetics in renal and hepatic insufficiency.