A Clinical Study of How Coffee and Tea Affect Enlicitide in Healthy Volunteers (MK-0616-040)

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: Enlicitide

Study type: Interventional

Funder types: Industry

Identifiers

NCT07044479

0616-040

MK-0616-040 (Other Identifier)

Details and patient eligibility

About

The goal of this study is to learn what happens to enlicitide in a person's body over time when enlicitide is taken at the same time as coffee or tea. Researchers will measure the amount of enlicitide in the blood when taken with coffee or tea compared with enlicitide taken with water.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

The key inclusion criteria include but are not limited to the following:

• Is in good health
• Is a non-smoker for at least 3 months prior to study entry
• Part 1 only: Consumes at least 1 cup of caffeinated coffee per day
• Part 2 only: Consumes at least 1 cup of caffeinated tea per day

Exclusion criteria

The key exclusion criteria include but are not limited to the following:

• Has a history or presence of clinically significant medical or psychiatric condition or disease
• History of gastrointestinal disease which might affect food and drug absorption, or has had gastric bypass or similar surgery.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

60 participants in 4 patient groups

Enlicitide Coffee Sequence 1

Experimental group

Description:

Participants will be randomized to receive enlicitide administered with water in period 1 and enlicitide with coffee in period 2.

Treatment:

Drug: Enlicitide

Enlicitide Coffee Sequence 2

Experimental group

Description:

Participants will be randomized to receive enlicitide administered with coffee in period 1 and enlicitide with water in period 2.

Treatment:

Drug: Enlicitide

Enlicitide Tea Sequence 1

Experimental group

Description:

Participants will be randomized to receive enlicitide administered with water in period 1 and enlicitide with tea in period 2.

Treatment:

Drug: Enlicitide

Enlicitide Tea Sequence 2

Experimental group

Description:

Participants will be randomized to receive enlicitide administered with tea in period 1 and enlicitide with water in period 2.

Treatment:

Drug: Enlicitide