A Clinical Study to Evaluate the Plasma Pharmacokinetics of a Single Dose of MK-4082 With and Without Diltiazem Coadministration in Healthy Participants
Merck Sharp & Dohme LLC
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.
Eligibility
- Age range
- 18–55 years
- Sex
- All
- 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 exclusion criteria include but are not limited to the following: * Has a history of previous surgical treatment for obesity that may induce malabsorption, history of bowel resection \>20 cm, any malabsorption disorder, severe gastroparesis, or any GI procedure for weight loss * Had a recent pancreatitis or has a history of pancreatitis
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.
Location
- Anaheim Clinical Trials ( Site 0001)Anaheim, California