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, Hepatitis, HIV, others

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

Compensation: Varies

Number of Visits: 169

Duration: 1 day

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of the study is to learn what happens to enlicitide decanoate in a healthy person's body over time when taken on an empty stomach or with food. Researchers will compare what happens to enlicitide in a healthy person's body over time when enlicitide is taken with or without food. Enlicitide decanoate will be referred to as "enlicitide" throughout.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for healthy adults with a BMI between 18 and 32. It's designed to understand how the body processes enlicitide, a drug, when taken with or without food.

Inclusion Criteria

My BMI is between 18 and 32.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single oral dose of enlicitide under different fasting conditions

1 day

1 visit (in-person)

Pharmacokinetic Monitoring

Participants are monitored for pharmacokinetic parameters of enlicitide in plasma

1 week

Multiple time points up to 168 hours post-dose

Follow-up

Participants are monitored for safety and adverse events

2 weeks

Treatment Details

Interventions

• Enlicitide

Trial Overview The study tests the effects of enlicitide on healthy individuals. Participants will take enlicitide either on an empty stomach or with food to see if there are any differences in how their bodies handle the drug.

Participant Groups

Group I: Enlicitide Treatment D Experimental Treatment 1 Intervention

Participants receive single oral dose of enlicitide 2 hours after morning meal.

Group II: Enlicitide Treatment C Experimental Treatment 1 Intervention

Participants receive single oral dose of enlicitide 3 hours after morning meal.

Group III: Enlicitide Treatment B Experimental Treatment 1 Intervention

Participants receive single oral dose of enlicitide 4 hours after morning meal.

Group IV: Enlicitide Treatment A Experimental Treatment 1 Intervention

Participants receive single oral dose of enlicitide after 8-hour overnight fast.

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