Clinical trial NCT06597760: A Clinical Study to Assess the Effect of Enlicitide on How the Body Processes Digoxin in Healthy Adult Participants (MK-0616-031)
Official title: A Clinical Study to Evaluate the Effect of Enlicitide on the Pharmacokinetics of Digoxin in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Celerion
First posted: 2024-09-19
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Researchers have designed a new study medicine called enlicitide decanoate 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.

The purpose of this study is to learn the effect of this new study medicine enlicitide on digoxin (medicine used in heart disease) over time (a pharmacokinetic or PK study). Researchers will compare what happens to digoxin in the body over time when it is given with this new study medicine enlicitide in healthy adult participants.


Eligibility criteria: Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

* Is in good health before randomization
* Has a body mass index (BMI) ≥18 and ≤32 kg/m\^2, inclusive

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* Has a history of clinically significant psychiatric, immunological, gastrointestinal, cardiovascular abnormalities or diseases.
* Has a history of cancer.
* Has positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at the screening visit.

Primary outcomes:
measure: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) for Digoxin in Plasma
timeFrame: At designated timepoints (up to 5 days)
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) for Digoxin in Plasma
timeFrame: At designated timepoints (up to 5 days)
measure: Cmax (Maximum Concentration) for Digoxin in Plasma
timeFrame: At designated timepoints (up to 5 days)
measure: Tmax (Time to Maximum Concentration) for Digoxin in Plasma
timeFrame: At designated timepoints (up to 5 days)
measure: Terminal half life (T½) for Digoxin in Plasma
timeFrame: At designated timepoints (up to 5 days)
measure: Apparent Clearance (CL/F) for Digoxin in Plasma
timeFrame: At designated timepoints (up to 5 days)
measure: Apparent Volume of Distribution During Terminal Phase (Vz/F) for Digoxin in Plasma
timeFrame: At designated timepoints (up to 5 days)
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs):
timeFrame: Up to ~ 28 days.
measure: Number of Participants With Clinical Laboratory Abnormalities
timeFrame: Up to ~ 28 days
measure: Standard and Orthostatic Vital Signs
timeFrame: Up to ~ 28 days
measure: 12-lead Electrocardiogram (ECGs)
timeFrame: Up to ~ 28days
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion ( Site 0001)
state: Nebraska
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: