Enlicitide for Healthy Subjects

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Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Merck Sharp & Dohme LLC

Disqualifiers: Gastrointestinal disease, Cancer, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of the study is to learn what happens to different forms of enlicitide medications in a healthy person's body over time. Researchers will compare the amount of enlicitide in the healthy person's body over time when enlicitide is given in different formulations.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for healthy adults who haven't smoked or used nicotine/tobacco products in the last 3 months. Participants should have a BMI between 18 and 32 kg/m^2.

Inclusion Criteria

I haven't smoked or used nicotine products for at least 3 months.

Has body mass index (BMI) ≥18 kg/m^2 and ≤32 kg/m^2

Exclusion Criteria

I have a history of stomach or intestine problems that affect how I absorb food and medicine, or I've had surgery like a gastric bypass.

Has positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)

I have had cancer before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single oral dose of enlicitide reference or test tablet

1 day

1 visit (in-person)

Pharmacokinetic Monitoring

Blood samples are collected to determine pharmacokinetic parameters of enlicitide

7 days

Multiple visits (in-person) for blood sampling

Follow-up

Participants are monitored for safety and effectiveness after treatment

14 days

What Are the Treatments Tested in This Trial?

Interventions

• Enlicitide

Trial Overview The study aims to understand how different formulations of a medication called Enlicitide behave in the body over time by measuring its levels after administration.

How Is the Trial Designed?

Group I: Treatment B: enlicitide test tablet Experimental Treatment 1 Intervention

Participants receive a single oral dose of enlicitide test tablet.

Group II: Treatment A: enlicitide reference tablet Experimental Treatment 1 Intervention

Participants receive a single oral dose of enlicitide reference tablet.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University