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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT07044479 (opens ClinicalTrials.gov in a new tab)Other id0616-040Other idMK-0616-040
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
60 participants (actual)
Sponsor
Merck Sharp & Dohme LLC · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
3 Jul 2025
Primary completion
13 Aug 2025
Completion
28 Aug 2025
First posted
1 Jul 2025
Last update posted
3 Sept 2025
Conditions
Healthy

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20252026
  1. Ph 1

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

    NCT07044479

    3 Jul 2025 to 28 Aug 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • EnlicitideDrug

Arms4

  • Experimental

    Enlicitide Coffee Sequence 1

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

  • Experimental

    Enlicitide Coffee Sequence 2

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

  • Experimental

    Enlicitide Tea Sequence 1

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

  • Experimental

    Enlicitide Tea Sequence 2

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

Primary outcomes6

Outcomes the sponsor listed as primary.

  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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

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

Secondary outcomes(4)

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

    Time frame · Up to approximately 7 weeks

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 55 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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.

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