A Clinical Study of Enlicitide and the Effect of Food in Healthy Adult Participants (MK-0616-033)

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06609512
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Enlicitide — DRUG
    Oral Tablet

Study Details

The goal of the study is to learn what happens to enlicitide decanoate in a healthy person's body over time when taken on an empty stomach or with food. Researchers will compare what happens to enlicitide in a healthy person's body over time when enlicitide is taken with or without food. Enlicitide decanoate will be referred to as "enlicitide" throughout.

Key Dates

Start date
Oct 21, 2024
Status verified
Feb 2025
Primary completion
Jan 13, 2025
Completion
Jan 31, 2025

Study Design

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

Arms

  • Experimental: Enlicitide Treatment A
    Participants receive single oral dose of enlicitide after 8-hour overnight fast.
  • Experimental: Enlicitide Treatment B
    Participants receive single oral dose of enlicitide 4 hours after morning meal.
  • Experimental: Enlicitide Treatment C
    Participants receive single oral dose of enlicitide 3 hours after morning meal.
  • Experimental: Enlicitide Treatment D
    Participants receive single oral dose of enlicitide 2 hours after morning meal.

Primary Outcome Measure

Area Under the Concentration versus Time Curve from 0 to Infinity (AUC0-inf) of enlicitide in plasma [ Time Frame: Pre-dose and at designated time points up to 168 hours post dose ]

Locations (1)

FacilityCityStateZIPSite coordinators
Celerion ( Site 0001)TempeArizona85283-

Find similar trials in Tempe, AZ

By research site
Celerion· Tempe, AZ

Related Studies