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

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT07044479
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Enlicitide — DRUG
    Single dose of enlicitide is administered orally on day 1 of each testing period

Study Details

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.

Key Dates

Start date
Jul 3, 2025
Status verified
Aug 2025
Primary completion
Aug 13, 2025
Completion
Aug 28, 2025

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • 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 Outcome Measure

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Celerion, Inc. ( Site 0001)TempeArizona85283-

Find similar trials in Tempe, AZ

By research site
Celerion, Inc.· Tempe, AZ

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