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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: enlicitide; Drug: lithium carbonate

Study type: Interventional

Funder types: Industry

Identifiers

NCT06719544

0616-034

MK-0616-034 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

The key inclusion criteria include but are not limited to the following:

• 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

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
• Has a history of cancer

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Lithium Carbonate

Experimental group

Description:

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

Treatment:

Drug: lithium carbonate

Enlicitide with Lithium Carbonate

Experimental group

Description:

On Day 1 of Period 2, a single oral dose of lithium carbonate will be coadministered with a single oral dose of enlicitide.

Treatment:

Drug: lithium carbonate

Drug: enlicitide