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

Phase 1

Not yet recruiting

• Conditions: Healthy
• Interventions: Drug: lithium carbonate; Drug: enlicitide

• Registration Number: NCT06719544
• Lead Sponsor: Merck Sharp & Dohme LLC

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.
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Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-02
• Study First Posted: 2024-12-06
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-13
• Study Start: 2025-01-02
• Primary Completion: 2025-02-06
• Study Completion: 2025-02-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 16

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lithium Carbonate	lithium carbonate	On Day 1 of Period 1, a single oral dose of lithium carbonate will be administered.
Enlicitide with Lithium Carbonate	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.
Enlicitide with Lithium Carbonate	enlicitide	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 Measures

Name	Time	Method
Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) for Lithium in Plasma	At designated timepoints (up to approximately 5 days post dose)	Blood samples will be collected to determine the AUC0-inf of lithium in plasma.
Area Under the Concentration versus Time Curve From Time Zero to Last Quantifiable Sample (AUC0-last) for Lithium in Plasma	At designated timepoints (up to approximately 5 days post dose)	Blood samples will be collected to determine the AUC0-last of lithium in plasma.
Cmax (Maximum Concentration) for Lithium in Plasma	At designated timepoints (up to approximately 5 days post dose)	Blood samples will be collected determine the Cmax of lithium in plasma.

Secondary Outcome Measures

Name	Time	Method
Number of Participants who experience a Treatment Emergent Adverse Event (TEAE)	Up to approximately 3 weeks	An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE will be considered treatment-emergent if the onset date and time is at the time of or after the first study drug administration. The number of pa...
Number of Participants Who Discontinue Study Due to a TEAE	Up to approximately 3 weeks	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE will be considered treatment-emergent if the onset date and time is at the time of or after the first study drug administration. The number of participants who d...