A Single- and Multiple-Dose Study of Enlicitide Chloride (MK-0616) in Healthy Chinese Adult Participants (MK 0616-010)

NCTNCT06814106Other id0616-010Other idMK-0616-010

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Overview

Status: Completed
Phase: Phase 1
Enrollment: 37 participants (actual)
Sponsor: Merck Sharp & Dohme LLC · Industry
Design: Randomized · Double masking
Countries: 1 country
China
Start: 6 Mar 2023
Primary completion: 8 May 2023
Completion: 8 May 2023
First posted: 7 Feb 2025
Last update posted: 7 Feb 2025
Conditions: Healthy

Timeline

1 trial · 1 completed

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

20232024

Ph 1
A Single- and Multiple-Dose Study of Enlicitide Chloride (MK-0616) in Healthy Chinese Adult Participants (MK 0616-010)
NCT06814106
6 Mar 2023 to 8 May 2023

Registry summary

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

The purpose of this study is to learn about the safety of enlicitide chloride and how well people tolerate it. Researchers also want to learn what happens to different amounts of enlicitide chloride in a healthy person's body over time.

Interventions

Enlicitide ChlorideDrug
PlaceboDrug

Arms3

Experimental
Enlicitide Chloride Panel A
Period 1: Participants will receive a single dose of enlicitide chloride dose 1 or a single dose of placebo on Day 1 on an empty stomach (after a ≥8-hour overnight fast). Period 2: Participants will receive a single dose of enlicitide chloride dose 1 or a single dose of placebo on Day 1 on an empty stomach (after a ≥8-hour overnight fast) followed by a standard breakfast.
Experimental
Enlicitide Chloride Panel B
Period 1: Participants will receive a single dose of enlicitide chloride dose 2 or a single dose of placebo on Day 1 on an empty stomach (after a ≥8-hour overnight fast). Period 2: Participants will receive a single dose of enlicitide chloride dose 3 or a single dose of placebo on Day 1 on an empty stomach (after a ≥8-hour overnight fast).
Experimental
Enlicitide Chloride Panel C
Participants will receive enlicitide chloride dose 2 or placebo once daily for 14 days on an empty stomach (after a ≥8-hour overnight fast).

Primary outcomes2

Outcomes the sponsor listed as primary.

Number of Participants Who Experience an Adverse Event (AE)
Time frame · Up to approximately 2 months
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
Number of Participants Who Discontinue the Study Treatment Due to an AE
Time frame · Up to approximately 2 months
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

Secondary outcomes(19)

Panels A and B: Area Under the Concentration-Time Curve from 0 to Infinity (AUC0-inf) of Enlicitide Chloride
Time frame · Predose and at designated timepoints (up to 8 days postdose)
Registry description
Blood samples will be collected to determine the AUC0-inf of enlicitide chloride
Panels A and B: Area Under the Concentration-Time Curve from 0 to 24 Hours (AUC0-24) of Enlicitide Chloride
Time frame · Predose and at designated timepoints (up to 24 hours postdose)
Registry description
Blood samples will be collected to determine the AUC0-24 of enlicitide chloride
Panels A and B: Area Under the Concentration-Time Curve from 0 to Last Measurable Concentration (AUC0-last) of Enlicitide Chloride
Time frame · Predose and at designated timepoints (up to 8 days postdose)
Registry description
Blood samples will be collected to determine the AUC0-last of enlicitide chloride
Panels A and B: Maximum Plasma Concentration (Cmax) of Enlicitide Chloride
Time frame · Predose and at designated timepoints (up to 8 days postdose)
Registry description
Blood samples will be collected to determine the Cmax of enlicitide chloride
Panels A and B: Time to Maximum Plasma Concentration (Tmax) of Enlicitide Chloride
Time frame · Predose and at designated timepoints (up to 8 days postdose)
Registry description
Blood samples will be collected to determine the Tmax of enlicitide chloride
Panels A and B: Concentration at 24 Hours Postdose (C24) of Enlicitide Chloride
Time frame · 24 hours postdose
Registry description
Blood samples will be collected to determine the C24 of enlicitide chloride
Panels A and B: Apparent Terminal Half-Life (t1/2) of Enlicitide Chloride
Time frame · Predose and at designated timepoints (up to 8 days postdose)
Registry description
Blood samples will be collected to determine the apparent terminal t1/2 of enlicitide chloride
Panels A and B: Apparent Clearance (CL/F) of Enlicitide Chloride
Time frame · Predose and at designated timepoints (up to 8 days postdose)
Registry description
Blood samples will be collected to determine the CL/F of enlicitide chloride
Panels A and B: Apparent Volume of Distribution During Terminal Phase (Vz/F) of Enlicitide Chloride
Time frame · Predose and at designated timepoints (up to 8 days postdose)
Registry description
Blood samples will be collected to determine the Vz/F of enlicitide chloride
Panels A and B: Percent of Reduction of Serum Low Density Lipoprotein Cholesterol (LDL-C)
Time frame · Predose and at designated timepoints (up to 8 days postdose)
Registry description
Blood samples will be collected to determine the percent of reduction of serum LDL-C
Panel C: AUC0-24 of Enlicitide Chloride
Time frame · Predose and at designated timepoints (up to 24 hours postdose)
Registry description
Blood samples will be collected to determine the AUC0-24 of enlicitide chloride
Panel C: Cmax of Enlicitide Chloride
Time frame · Predose and at designated timepoints (up to 14 days postdose)
Registry description
Blood samples will be collected to determine the Cmax of enlicitide chloride
Panel C: Tmax of Enlicitide Chloride
Time frame · Predose and at designated timepoints (up to 14 days postdose)
Registry description
Blood samples will be collected to determine the Tmax of enlicitide chloride
Panel C: C24 of Enlicitide Chloride
Time frame · 24 hours postdose
Registry description
Blood samples will be collected to determine the C24 of enlicitide chloride
Panel C: Apparent Terminal t1/2 of Enlicitide Chloride
Time frame · Predose and at designated timepoints (up to 14 days postdose)
Registry description
Blood samples will be collected to determine the apparent terminal t/2 of enlicitide chloride
Panel C: CL/F of Enlicitide Chloride
Time frame · Predose and at designated timepoints (up to 14 days postdose)
Registry description
Blood samples will be collected to determine the CL/F of enlicitide chloride
Panel C: Vz/F of Enlicitide Chloride
Time frame · Predose and at designated timepoints (up to 14 days postdose)
Registry description
Blood samples will be collected to determine the Vz/F of enlicitide chloride
Panel C: Accumulation Ratio of Enlicitide Chloride
Time frame · Predose and at designated timepoints (up to 14 days postdose)
Registry description
Blood samples will be collected to determine the accumulation ratio of enlicitide chloride
Panel C: Percent of Reduction of Serum LDL-C
Time frame · Predose and at designated timepoints (up to 14 days postdose)
Registry description
Blood samples will be collected to determine the percent of reduction of serum LDL-C

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: Male
Age: from 18 Years up to 50 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: Inclusion criteria include, but are not limited to: * Is in good health * Has a body mass index ≥19.0 and ≤26.0 kg/m\^2, inclusive Exclusion Criteria: Exclusion criteria include, but are not limited to: * Has a history of gastrointestinal disease * Has a history of cancer (malignancy)

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