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

NCTNCT06719544Other id0616-034Other idMK-0616-034

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Overview

Status: Completed
Phase: Phase 1
Enrollment: 16 participants (actual)
Sponsor: Merck Sharp & Dohme LLC · Industry
Design: Not randomized · Open label (no masking)
Countries: 1 country
United States
Start: 2 Jan 2025
Primary completion: 27 Jan 2025
Completion: 6 Feb 2025
First posted: 6 Dec 2024
Last update posted: 17 Feb 2025
Conditions: Healthy

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20252026

Ph 1
A Study of Lithium and Enlicitide in Healthy Adult Participants (MK-0616-034)
NCT06719544
2 Jan 2025 to 6 Feb 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

lithium carbonateDrug
enlicitideDrug

Arms2

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 outcomes3

Outcomes the sponsor listed as primary.

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)
Registry description
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
Time frame · At designated timepoints (up to approximately 5 days post dose)
Registry description
Blood samples will be collected to determine the AUC0-last of lithium in plasma.
Cmax (Maximum Concentration) for Lithium in Plasma
Time frame · At designated timepoints (up to approximately 5 days post dose)
Registry description
Blood samples will be collected determine the Cmax of lithium in plasma.

Secondary outcomes(2)

Number of Participants who experience a Treatment Emergent Adverse Event (TEAE)
Time frame · Up to approximately 3 weeks
Registry description
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 participants who experience a TEAE will be reported.
Number of Participants Who Discontinue Study Due to a TEAE
Time frame · Up to approximately 3 weeks
Registry description
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 discontinue study due to a TEAE will be reported.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 55 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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

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