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Completed

NCT Number: NCT07044479

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion, Inc. ( Site 0001)

Tempe, Arizona, 85283, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Enlicitide

Drug

Single dose of enlicitide is administered orally on day 1 of each testing period

Other names: MK-0616, enlicitide decanoate

Primary outcomes

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

    Time frame: Predose and at designated time points up to 168 hours

    Blood samples will be collected to determine the AUC0-inf of enlicitide when administered with coffee

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

    Time frame: Predose and at designated time points up to 168 hours

    Blood samples will be collected to determine the AUC from time 0 to the time of last quantifiable sample of enlicitide when administered with coffee

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

    Time frame: Predose and at designated time points up to 168 hours

    Blood samples will be collected to determine the maximum observed drug concentration of enlicitide when administered with coffee

  4. Part 2 -Tea: AUC0-last of Enlicitide

    Time frame: Predose and at designated time points up to 168 hours

    Blood samples will be collected to determine the AUC from time 0 to the time of last quantifiable sample of enlicitide when administered with tea

  5. Part 2 - Tea: AUC0-Inf of Enlicitide

    Time frame: Predose and at designated time points up to 168 hours

    Blood samples will be collected to determine the AUC0-inf of enlicitide when administered with tea.

  6. Part 2 -Tea: Cmax of Enlicitide

    Time frame: Predose and at designated time points up to 168 hours

    Blood samples will be collected to determine the maximum observed drug concentration of enlicitide when administered with tea

Secondary outcomes

  1. Part 1 - Coffee: Number of Participants Who Experience an Adverse Event (AE)

    Time frame: Up to approximately 7 weeks

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.

  2. Part 2 - Tea: Number of Participants Who Experience an Adverse Event (AE)

    Time frame: Up to approximately 7 weeks

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.

  3. Part 1 - Coffee: Number of Participants Who Discontinue Study Treatment Due to an AE

    Time frame: Up to approximately 7 weeks

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.

  4. Part 2 - Tea: Number of Participants Who Discontinue Study Treatment Due to an AE

    Time frame: Up to approximately 7 weeks

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Clinical Study to Evaluate the Effects of Coffee and Tea on the Pharmacokinetics of Enlicitide in Healthy Adult Participants

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 1, 2025
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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