CompletedPhase 1

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

United States60 participantsStarted 2025-07-03

Plain-language summary

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.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part 1-Coffee: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Enlicitide

Timeframe: Predose and at designated time points up to 168 hours

Part 1-Coffee: Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-last) of Enlicitide

Timeframe: Predose and at designated time points up to 168 hours

Part 1 -Coffee : Maximum Plasma Concentration (Cmax) of Enlicitide

Timeframe: Predose and at designated time points up to 168 hours

Part 2 -Tea: AUC0-last of Enlicitide

Timeframe: Predose and at designated time points up to 168 hours

Part 2 - Tea: AUC0-Inf of Enlicitide

Timeframe: Predose and at designated time points up to 168 hours

Part 2 -Tea: Cmax of Enlicitide

Timeframe: Predose and at designated time points up to 168 hours

Trial details

NCT IDNCT07044479

SponsorMerck Sharp & Dohme LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-08-13

View on ClinicalTrials.gov More Healthy trials

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Part 1-Coffee: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Enlicitide

Timeframe: Predose and at designated time points up to 168 hours

Part 1-Coffee: Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-last) of Enlicitide

Timeframe: Predose and at designated time points up to 168 hours

Part 1 -Coffee : Maximum Plasma Concentration (Cmax) of Enlicitide

Timeframe: Predose and at designated time points up to 168 hours

Part 2 -Tea: AUC0-last of Enlicitide

Timeframe: Predose and at designated time points up to 168 hours

Part 2 - Tea: AUC0-Inf of Enlicitide

Timeframe: Predose and at designated time points up to 168 hours

Part 2 -Tea: Cmax of Enlicitide

Timeframe: Predose and at designated time points up to 168 hours