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Completed

NCT Number: NCT06597760

A Clinical Study to Assess the Effect of Enlicitide on How the Body Processes Digoxin in Healthy Adult Participants (MK-0616-031)

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.

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Key information

Conditions

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion ( Site 0001)

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Enlicitide

Drug

Participants will receive 20 mg enlicitide/180 mg sodium caprate coadministered with 0.25mg Digoxin orally on Day 1, Period 2 in Arm A and on Day 1 Period 1 in Arm B.

Other names: enlicitide decanoate, MK-0616/sodium caprate

Digoxin

Drug

Participants will receive 0.25 mg digoxin orally on Day 1 Period 1 in Arm A and Day 1 Period 2 in Arm B. They also receive Digoxin orally on Day 1, Period 2 in Arm A and on Day 1 Period 1 in Arm B coadministered with oral 20 mg enlicitide/180 mg sodium caprate.

Primary outcomes

  1. Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) for Digoxin in Plasma

    Time frame: At designated timepoints (up to 5 days)

    AUC0-inf is the area under the plasma concentration versus time curve (AUC) for digoxin, from time zero (pre-dose) to extrapolated infinite time.

Secondary outcomes

  1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) for Digoxin in Plasma

    Time frame: At designated timepoints (up to 5 days)

    Area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration is at or above the lower limit of quantification (LLQ).

  2. Cmax (Maximum Concentration) for Digoxin in Plasma

    Time frame: At designated timepoints (up to 5 days)

    Blood samples will be collected at at designated timepoints (up to 5 days) post-dose to determine the Cmax of Digoxin.

  3. Tmax (Time to Maximum Concentration) for Digoxin in Plasma

    Time frame: At designated timepoints (up to 5 days)

    The time to reach Cmax (Tmax) is determined. Blood samples will be collected at designated timepoints (up to 5 days) post-dose to determine the maximum concentration (Cmax) of digoxin.

  4. Terminal half life (T½) for Digoxin in Plasma

    Time frame: At designated timepoints (up to 5 days)

    T1/2 is defined as the time taken for the plasma concentration or the amount of digoxin in the body to be reduced by half.

  5. Apparent Clearance (CL/F) for Digoxin in Plasma

    Time frame: At designated timepoints (up to 5 days)

    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.

  6. Apparent Volume of Distribution During Terminal Phase (Vz/F) for Digoxin in Plasma

    Time frame: At designated timepoints (up to 5 days)

    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/f after oral dose of digoxin is influenced by the fraction absorbed.

  7. Number of Participants With Treatment Emergent Adverse Events (TEAEs):

    Time frame: Up to ~ 28 days.

    An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs are defined as all AEs that occurred at or after the first dose of the investigational product and through the last follow-up date.

  8. Number of Participants With Clinical Laboratory Abnormalities

    Time frame: Up to ~ 28 days

    Clinical laboratory test include serum chemistry, hematology and urinalysis. Clinical laboratory abnormalities were recorded and reported as TEAE. TEAEs are defined as all AEs that occurred at or after the first dose of the investigational product or device implant surgery (whichever occurred earlier) and through the last follow-up date.

  9. Standard and Orthostatic Vital Signs

    Time frame: Up to ~ 28 days

    Single measurements of body temperature, respiratory rate, blood pressure, and heart rate, and triplicate measurements of blood pressure and heart rate will be measured. Orthostatic vital signs (i.e., heart rate and blood pressure) will be measured, Measurements will be collected with participants in a semi-recumbent position and then collected when in a standing position.

  10. 12-lead Electrocardiogram (ECGs)

    Time frame: Up to ~ 28days

    Single and triplicate 12-lead ECGs will be performed. Triplicate 12-lead ECGs will be performed within an approximately 6-minute time window. ECGs will be performed with participants in a supine position for at least 5 minutes. In each period, triplicate ECGs will be measured within 3 hours prior to dosing. When scheduled post dose, single ECGs will be performed within ±20 minutes of the scheduled time point.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

  • Celerion

Registry information

Official study title

A Clinical Study to Evaluate the Effect of Enlicitide on the Pharmacokinetics of Digoxin in Healthy Adult Participants

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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