A Study of Lithium and Enlicitide in Healthy Adult Participants (MK-0616-034)

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06719544
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • lithium carbonate — DRUG
    Oral capsule
  • enlicitide — DRUG
    Oral tablet

Study Details

Researchers have designed a new study medicine called enlicitide decanoate (MK-0616) as a new way to lower the amount of low-density lipoprotein cholesterol (LDL-C) in a person's blood. Enlicitide decanoate will be called "enlicitide" from this point forward. Lithium (also called lithium carbonate) is a medicine used in bipolar disorder. Researchers want to learn about lithium when taken at the same time with enlicitide. They want to: * Measure a person's blood to find out if the amount of lithium in the blood is the same when lithium is taken alone or with enlicitide * Learn about the safety of lithium when taken alone or with enlicitide and if people tolerate it

Key Dates

Start date
Jan 2, 2025
Status verified
Feb 2025
Primary completion
Jan 27, 2025
Completion
Feb 6, 2025

Study Design

Enrollment
16 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Lithium Carbonate
    On Day 1 of Period 1, a single oral dose of lithium carbonate will be administered.
  • Experimental: Enlicitide with Lithium Carbonate
    On Day 1 of Period 2, a single oral dose of lithium carbonate will be coadministered with a single oral dose of enlicitide.

Primary Outcome Measure

Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) for Lithium in Plasma [ Time Frame: At designated timepoints (up to approximately 5 days post dose) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Celerion ( Site 0002)TempeArizona85283-

Find similar trials in Tempe, AZ

By research site
Celerion· Tempe, AZ

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