Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [¹⁴C]Enlicitide chloride, MK-0616
Enlicitide Chloride · 3 trials · 3 indications
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.
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Blood samples were collected at pre-specified timepoints to determine the AUC0-last of MK-0616. AUC0-last was defined as the area under the concentration-time curve of MK-0616 from time zero to last measurable concentration.
Blood samples were collected at pre-specified timepoints to determine the CL/F of MK-0616. CL/F was the apparent total clearance of MK-0616 in plasma over time, assessed as the rate at which MK-0616 was removed from the plasma.
Blood samples were collected at pre-specified timepoints to determine the Vz/F of MK-0616. Vz/F was the apparent volume of distribution of MK-0616 between the plasma and the rest of the body, after dose, assessed as the total volume of MK-0616 that would need to be uniformly distributed to achieve the desired plasma drug concentration.
| 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. |
| Enlicitide Chloride | EXPERIMENTAL | Participants receive enlicitide chloride titrated orally from Dose 1, Dose 2, or Dose 3 once daily (QD) over the course of a 14-day treatment for each dose based on the safety and tolerability of the previous starting dose. The total treatment duration is up to approximately 6 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants receive placebo orally for up to approximately 6 weeks. |
| Panel A - Moderate Renal Impairment (RI) | EXPERIMENTAL | Single dose of enlicitide chloride 10 mg |
| Panel B - Healthy Controls | EXPERIMENTAL | Single dose of enlicitide chloride 10 mg |
| Name | Type | Description |
|---|---|---|
| MK-0616 | DRUG | oral administration |
| Enlicitide Chloride | BIOLOGICAL | Oral administration |
| Placebo | OTHER | 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...
Enlicitide chloride is an investigational monoclonal antibody being developed by Merck & Company, Inc. (MRK) for hypercholesterolemia and moderate renal impairment. It is in Phase 1 clinical development and has been studied in placebo-controlled, randomized, double-blind trials. It is not approved for any indication.
Enlicitide chloride is being studied for hypercholesterolemia and for use in people with moderate renal impairment. Clinical trials have enrolled healthy participants, participants taking statins, and participants with moderate renal impairment. It remains investigational and has not been approved for any use.
Enlicitide chloride is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is running the clinical program for the drug, including the Phase 1 studies conducted in the United States.
Enlicitide chloride is in Phase 1 clinical development. Its trials are listed as completed, and it is an investigational agent that has not been approved by the FDA. The program has studied the drug in healthy participants, participants taking statins, and participants with moderate renal impairment.
Enlicitide chloride has been evaluated in Phase 1 trials including NCT06655311, which studied it in healthy participants and participants taking statins, and NCT05070390, which studied it in participants with moderate renal impairment. Both trials are completed and were conducted in the United States.
Yes. [¹⁴C]Enlicitide chloride is an alternative name for enlicitide chloride, referring to the carbon-14 labeled form used in study work. Both names refer to the same Merck (MRK) investigational compound being studied in Phase 1 trials.