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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06658626 | A Study to Evaluate the Metabolism, Excretion, and Mass Balance of [¹⁴C]Enlicitide Chloride ([¹⁴C]MK-0616) in Healthy Participants (MK-0616-016) | PHASE1 | COMPLETED | 8 | — | — | Mar 10, 2023 | Aug 2, 2023 | Oct 26, 2024 | 1 | United States |
| NCT06814106 | A Single- and Multiple-Dose Study of Enlicitide Chloride (MK-0616) in Healthy Chinese Adult Participants (MK 0616-010) | PHASE1 | COMPLETED | 37 | — | — | Mar 6, 2023 | May 8, 2023 | Feb 7, 2025 | 1 | China |
| NCT06655311 | A Study of Enlicitide Chloride (MK-0616) in Healthy Participants and Participants Taking Statins (MK-0616-012) | PHASE1 | COMPLETED | 56 | — | — | Sep 30, 2022 | Jan 2, 2024 | Oct 23, 2024 | 1 | United States |
Urine samples will be collected to determine the Aeu of \[¹⁴C\]enlicitide chloride.
Fecal samples will be collected to determine the Aef of \[¹⁴C\]enlicitide chloride.
Urine samples will be collected to determine the feu of \[¹⁴C\]enlicitide chloride.
Fecal samples will be collected to determine the fef of \[¹⁴C\]enlicitide chloride.
Plasma samples will be collected to determine the AUC0-t of enlicitide chloride.
Plasma samples will be collected to determine the AUC0-inf of enlicitide chloride.
Plasma samples will be collected to determine the Cmax of enlicitide chloride.
Plasma samples will be collected to determine the t1/2 of enlicitide chloride.
Plasma samples will be collected to determine the Tmax of enlicitide chloride.
Plasma samples will be collected to determine the AUC0-t of total reactivity.
Plasma samples will be collected to determine the AUC0-inf of total reactivity.
Plasma samples will be collected to determine the Cmax of total reactivity.
Plasma samples will be collected to determine the t1/2 of total reactivity.
Plasma samples will be collected to determine the Tmax of total reactivity.
Plasma samples will be collected to determine the enlicitide chloride AUC0-x/total radioactivity AUC0-x.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention
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.
| Arm | Type | Description |
|---|---|---|
| [¹⁴C]Enlicitide chloride | EXPERIMENTAL | Participants will receive a single dose of \[¹⁴C\]enlicitide chloride on Day 1. |
| Enlicitide Chloride Panel A | EXPERIMENTAL | Period 1: Participants will receive a single dose of enlicitide chloride dose 1 or a single dose of placebo on Day 1 on an empty stomach (after a ≥8-hour overnight fast). Period 2: Participants will receive a single dose of enlicitide chloride dose 1 or a single dose of placebo on Day 1 on an empty stomach (after a ≥8-hour overnight fast) followed by a standard breakfast. |
| Enlicitide Chloride Panel B | EXPERIMENTAL | Period 1: Participants will receive a single dose of enlicitide chloride dose 2 or a single dose of placebo on Day 1 on an empty stomach (after a ≥8-hour overnight fast). Period 2: Participants will receive a single dose of enlicitide chloride dose 3 or a single dose of placebo on Day 1 on an empty stomach (after a ≥8-hour overnight fast). |
| Enlicitide Chloride Panel C | EXPERIMENTAL | Participants will receive enlicitide chloride dose 2 or placebo once daily for 14 days on an empty stomach (after a ≥8-hour overnight fast). |
| 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. |
| Name | Type | Description |
|---|---|---|
| [¹⁴C]Enlicitide chloride | DRUG | IV Injection |
| Enlicitide Chloride | DRUG | Oral Capsule |
| Placebo | DRUG | Placebo oral capsule matching enlicitide chloride |
Inclusion Criteria: * Is in good health. * Has a body mass index ≥18 and ≤32 kg/m\^2, inclusive. Exclusion Criteria: * Has a history of cancer. * Has positive tests for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus.