Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-0616 · 1 trial · 1 indication
Blood samples will be collected to determine the AUC0-inf of MK-0616.
Blood samples will be collected to determine the AUC0-24 of MK-0616.
Blood samples will be collected to determine the AUC0-last of MK-0616.
Blood samples will be collected to determine the Cmax of MK-0616.
Blood samples will be collected to determine the C24 of MK-0616.
Blood samples will be collected to determine the apparent t1/2 of MK-0616.
Blood samples will be collected at pre-specified timepoints to determine the Tmax of MK-0616.
| Arm | Type | Description |
|---|---|---|
| Sequence 1: MK-0616 Reference capsule→MK-0616 Formulation 1 (F1)→MK-0616 Formulation 2 (F2) | EXPERIMENTAL | Period 1: Participants receive MK-0616 reference capsule single dose on Day 1 orally (Period 1 = 15 days). Period 2: Participants receive MK-0616 F1 single dose on Day 1 orally (Period 2 = 15 days). Period 3: Participants receive MK-0616 F2 single dose on Day 1 orally (Period 3 = 15 days). A washout period of 14 days will separate Period 1, Period 2 and Period 3. |
| Sequence 2: MK-0616 Reference capsule→MK-0616 F2→MK-0616 F1 | EXPERIMENTAL | Period 1: Participants receive MK-0616 reference capsule single dose on Day 1 orally (Period 1 = 15 days). Period 2: Participants receive MK-0616 F2 single dose on Day 1 orally (Period 2 = 15 days). Period 3: Participants receive MK-0616 F1 single dose on Day 1 orally (Period 3 = 15 days). A washout period of 14 days will separate Period 1, Period 2 and Period 3. |
| Sequence 3: MK-0616 F1→MK-0616 Reference capsule→MK-0616 F2 | EXPERIMENTAL | Period 1: Participants receive MK-0616 F1 single dose on Day 1 orally (Period 1 = 15 days). Period 2: Participants receive MK-0616 reference capsule single dose on Day 1 orally (Period 2 = 15 days). Period 3: Participants receive MK-0616 F2 single dose on Day 1 orally (Period 3 = 15 days). A washout period of 14 days will separate Period 1, Period 2 and Period 3. |
| Sequence 4: MK-0616 F1→MK-0616 F2→MK-0616 Reference capsule | EXPERIMENTAL | Period 1: Participants receive MK-0616 F1 single dose on Day 1 orally (Period 1 = 15 days). Period 2: Participants receive MK-0616 F2 single dose on Day 1 orally (Period 2 = 15 days). Period 3: Participants receive MK-0616 reference capsule single dose on Day 1 orally (Period 3 = 15 days). A washout period of 14 days will separate Period 1, Period 2 and Period 3. |
| Sequence 5: MK-0616 F2→MK-0616 Reference capsule →MK-0616 F1 | EXPERIMENTAL | Period 1: Participants receive MK-0616 F2 single dose on Day 1 orally (Period 1 = 15 days). Period 2: Participants receive MK-0616 reference capsule single dose on Day 1 orally (Period 2 = 15 days). Period 3: Participants receive MK-0616 F1 single dose on Day 1 orally (Period 3 = 15 days). A washout period of 14 days will separate Period 1, Period 2 and Period 3. |
| Sequence 6: MK-0616 F2→MK-0616 F1→MK-0616 Reference capsule | EXPERIMENTAL | Period 1: Participants receive MK-0616 F2 single dose on Day 1 orally (Period 1 = 15 days). Period 2: Participants receive MK-0616 F1 single dose on Day 1 orally (Period 2 = 15 days). Period 3: Participants receive MK-0616 reference capsule single dose on Day 1 orally (Period 3 = 15 days). A washout period of 14 days will separate Period 1, Period 2 and Period 3. |
| Name | Type | Description |
|---|---|---|
| MK-0616 | DRUG | oral administration |
Inclusion Criteria: The key inclusion criteria include but are not limited to the following: * Is in good health before randomization * Has a body mass index (BMI) ≥18 and ≤32 kg/m\^2, inclusive Exclusion Criteria: The key exclusion criteria include but are not limited to the following: * Has a...
MK-0616 is an investigational small molecule being developed for the treatment of hypercholesterolemia, a condition characterized by high levels of cholesterol in the blood. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
MK-0616 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in Phase 1 clinical development for hypercholesterolemia.
MK-0616 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is being studied for the treatment of hypercholesterolemia.
MK-0616 has one completed Phase 1 clinical trial, identified as NCT06592339, titled "A Study of MK-0616 in Healthy Adult Participants (MK-0616-009)". The trial enrolled 24 participants in the United States and was a controlled, randomized study.
MK-0616 is the primary name for this investigational drug. No alternative names have been reported for this compound in the available clinical trial information.