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Enlicitide Interaction Study in Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~ 28days
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test a new medication called enlicitide to see if it can help lower LDL-C levels. The study will focus on how enlicitide interacts with another medication, digoxin

Who is the study for?
This trial is for healthy adults with a BMI between 18 and 32. Participants should be in good health before joining the study.
What is being tested?
The study tests how enlicitide affects the body's processing of digoxin, a heart disease medication. It will compare what happens to digoxin when taken alone versus with enlicitide over time.
What are the potential side effects?
As this summary is about a clinical trial assessing drug interactions rather than side effects, specific side effects are not provided here. Generally, participants may experience reactions related to either digoxin or enlicitide.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~ 28days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~ 28days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) for Digoxin in Plasma
Secondary study objectives
12-lead Electrocardiogram (ECGs)
Apparent Clearance (CL/F) for Digoxin in Plasma
Apparent Volume of Distribution During Terminal Phase (Vz/F) for Digoxin in Plasma
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Sequence 2: 0.25mg Digoxin plus 20mg enlicitide/180mg Sodium Caprate-->0.25mg DigoxinExperimental Treatment2 Interventions
Participants will receive 1 tablet of 0.25mg Digoxin coadministered with 1 tablet of 20 mg enlicitide/180 mg sodium caprate on Day 1 of Period 1 and will receive 1 tablet of 0.25mg Digoxin on Day 1 of period 2.
Group II: Sequence 1: 0.25mg Digoxin-->0.25mg Digoxin plus 20mg enlicitide/180mg Sodium CaprateExperimental Treatment2 Interventions
Participants will receive 1 tablet of 0.25mg Digoxin on Day 1 of period 1 and 1 tablet of 0.25mg Digoxin coadministered with 1 tablet of 20 mg enlicitide/180 mg sodium caprate on Day 1 of Period 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Digoxin
2017
Completed Phase 4
~670

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

CelerionIndustry Sponsor
83 Previous Clinical Trials
7,842 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
4,005 Previous Clinical Trials
5,185,414 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,882 Previous Clinical Trials
8,089,139 Total Patients Enrolled
~16 spots leftby Nov 2025
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