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

NCT06719544 | Completed Phase 1 FDA Drug

• 2 other identifiers: 0616-034MK-0616-034
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) for Lithium in Plasma

  Blood samples will be collected to determine the AUC0-inf of lithium in plasma.

  At designated timepoints (up to approximately 5 days post dose)

• Area Under the Concentration versus Time Curve From Time Zero to Last Quantifiable Sample (AUC0-last) for Lithium in Plasma

  Blood samples will be collected to determine the AUC0-last of lithium in plasma.

  At designated timepoints (up to approximately 5 days post dose)

• Cmax (Maximum Concentration) for Lithium in Plasma

  Blood samples will be collected determine the Cmax of lithium in plasma.

  At designated timepoints (up to approximately 5 days post dose)

Secondary Outcomes (2)

• Number of Participants who experience a Treatment Emergent Adverse Event (TEAE)

  Up to approximately 3 weeks

• Number of Participants Who Discontinue Study Due to a TEAE

  Up to approximately 3 weeks

Study Arms (2)

Lithium Carbonate

EXPERIMENTAL

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

Drug: lithium carbonate

Enlicitide with Lithium Carbonate

EXPERIMENTAL

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

Drug: lithium carbonate; Drug: enlicitide

Interventions

lithium carbonate DRUG

Oral capsule

Also known as: lithium

Enlicitide with Lithium Carbonate; Lithium Carbonate

enlicitide DRUG

Oral tablet

Also known as: enlicitide decanoate, MK-0616/sodium caprate

Enlicitide with Lithium Carbonate

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Has a history or presence of clinically significant medical or psychiatric condition or disease
• Has a history of cancer

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Celerion ( Site 0002)

Tempe, Arizona, 85283, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

Lithium Carbonate; Lithium

Intervention Hierarchy (Ancestors)

Carbonates; Alkalies; Inorganic Chemicals; Carbonic Acid; Carbon Compounds, Inorganic; Lithium Compounds; Metals, Alkali; Elements; Metals, Light; Metals

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 6, 2024
• Study Start: January 2, 2025
• Primary Completion: January 27, 2025
• Study Completion: February 6, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)