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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-02

Study Completion Date

2025-02-06

Brief Summary

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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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Lithium Carbonate

On Day 1 of Period 1, a single oral dose of lithium carbonate will be administered.

Group Type EXPERIMENTAL

lithium carbonate

Intervention Type DRUG

Oral capsule

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.

Group Type EXPERIMENTAL

lithium carbonate

Intervention Type DRUG

Oral capsule

enlicitide

Intervention Type DRUG

Oral tablet

Interventions

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lithium carbonate

Oral capsule

Intervention Type DRUG

enlicitide

Oral tablet

Intervention Type DRUG

Other Intervention Names

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lithium enlicitide decanoate MK-0616/sodium caprate

Eligibility Criteria

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Inclusion Criteria

* Is medically healthy with no clinically significant medical history
* Is a continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing