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| ID | Type | Description | Link |
|---|---|---|---|
| MK-4082-005 | Other Identifier | MSD |
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Researchers are looking for new weight loss medicines for people with higher body weight. The trial medicine, MK-4082, is different from similar weight loss medicines because people take it as a pill instead of an injection. Before giving a trial medicine to participants with a health condition, researchers first do trials in healthy participants to find a safe dose level (amount) of the trial medicine.
The goal of this study is to learn what happens to MK-4082 in a person's body over time. Researchers will compare what happens to levels of MK-4082 in people's blood when it is taken without (Period 1) and with (Period 2) another medicine called diltiazem. Researchers also want to learn about the safety of MK-4082 taken with and without diltiazem and if people tolerate them.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-4082 + Diltiazem | Experimental | Participants will move sequentially through 2 periods. In Period 1, participants will receive a single oral dose of MK-4082 on Day 1. In Period 2, participants will receive a single oral dose of MK-4082 on Day 1 plus oral diltiazem for multiple days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-4082 | Drug | Oral administration |
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| Diltiazem |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MK-4082 | Blood samples will be collected to determine the AUC0-inf of MK-4082. | At designated timepoints (up to approximately 1 week postdose) |
| Maximum Plasma Concentration (Cmax) of MK-4082 | Blood samples will be collected to determine the Cmax of MK-4082. | At designated timepoints (up to approximately 1 week postdose) |
| Number of Participants Who Experience an Adverse Event (AE) | 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. The number of participants who experience an AE will be reported. | Up to approximately 31 days |
| Number of Participants Who Discontinue Study Intervention Due to an AE | 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. The number of participants who discontinue study intervention due to an AE will be reported. | Up to approximately 17 days |
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| D004110 | Diltiazem |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
Oral administration |
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| Rescue medication | Drug | All participants will receive ondansetron as a rescue medication. Ondansetron is a medication used to prevent nausea or vomiting. |
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