A Clinical Trial of MK-4082 in Healthy Participants (MK-4082-005)

Purpose

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.

Condition

  • Healthy

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Sequential Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)
Masking Description
Part 1 of the study is open label with no control. Part 2 of the study is double-blind and placebo-controlled.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
MK-4082 		Participants will move sequentially through 2 periods in Part 1. 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. In Part 2 participants receive a single dose of MK-4082 or placebo.
  • Drug: MK-4082
    Oral administration
  • Drug: Diltiazem
    Oral administration
  • Drug: Rescue medication
    All participants will receive ondansetron as a rescue medication. Ondansetron is a medication used to prevent nausea or vomiting.

Recruiting Locations

Anaheim Clinical Trials ( Site 0001)
Anaheim, California 92801
Contact:
Study Coordinator
714-774-7777

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com