Healthy
Conditions
Brief summary
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 alone (Part 1, Period 1 and Part 2) and in combination with (Part 1, 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.
Interventions
DRUGMK-4082
Oral administration
DRUGDiltiazem
Oral administration
DRUGRescue medication
All participants will receive ondansetron as a rescue medication. Ondansetron is a medication used to prevent nausea or vomiting.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
Part 1 of the study is open label with no control. Part 2 of the study is double-blind and placebo-controlled.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
The main inclusion criteria include but are not limited to the following: * Is in good health * Body mass index (BMI) between 18 and 32 kg/m\^2, inclusive
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-∞) of MK-4082 | At designated timepoints (up to approximately 1 week postdose) | Blood samples will be collected to determine the AUC0-∞ of MK-4082. |
| Part 1: Maximum Plasma Concentration (Cmax) of MK-4082 | At designated timepoints (up to approximately 1 week postdose) | Blood samples will be collected to determine the Cmax of MK-4082. |
| Part 1: Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 31 days | 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. |
| Part 1: Number of Participants Who Discontinue Study Intervention Due to an AE | Up to approximately 17 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 2: AUC0-∞ of MK-4082 | At designated timepoints (up to approximately 1 week postdose) | Blood samples will be collected to determine the AUC0-∞ of MK-4082. |
| Part 2: AUC0-24 of MK-4082 | At designated timepoints (up to 24 hours postdose) | Blood samples will be collected to determine the AUC0-24 of MK-4082. |
| Part 2: Cmax of MK-4082 | At designated timepoints (up to approximately 1 week postdose) | Blood samples will be collected to determine the Cmax of MK-4082. |
| Part 2: Time to maximum plasma concentration (Tmax) of MK-4082 | At designated timepoints (up to approximately 1 week postdose) | Blood samples will be collected to determine the Tmax of MK-4082. |
| Part 2: Plasma concentration 24 hours postdose (C24) of MK-4082 | 24 hours postdose | Blood samples will be collected to determine the C24 of MK-4082. |
| Part 2: Apparent terminal half-life (t½) of MK-4082 | At designated timepoints (up to approximately 1 week postdose) | Blood samples will be collected to determine the t½ of MK-4082. |
Countries
United States
Contacts
CONTACTToll Free Number
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed