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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06592339 | A Study of MK-0616 in Healthy Adult Participants (MK-0616-009) | PHASE1 | COMPLETED | 24 | — | — | Oct 25, 2022 | Dec 29, 2022 | Sep 19, 2024 | 1 | United States |
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...