A Phase 1 interventional study of Enlicitide and Digoxin in Healthy, sponsored by Merck Sharp & Dohme LLC. Completed at 1 site in United States. Open to participants aged 19 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-29.
Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Basic science
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.
Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
The key inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The key exclusion criteria include but are not limited to the following:
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.
Drug: Enlicitide · Drug: Digoxin
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.
Drug: Enlicitide · Drug: Digoxin
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.
Also known as: enlicitide decanoate, MK-0616/sodium caprate
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.
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) for Digoxin in Plasma
AUC0-inf is the area under the plasma concentration versus time curve (AUC) for digoxin, from time zero (pre-dose) to extrapolated infinite time.
Time frame: At designated timepoints (up to 5 days)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) for Digoxin in Plasma
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).
Time frame: At designated timepoints (up to 5 days)
Cmax (Maximum Concentration) for Digoxin in Plasma
Blood samples will be collected at at designated timepoints (up to 5 days) post-dose to determine the Cmax of Digoxin.
Time frame: At designated timepoints (up to 5 days)
Tmax (Time to Maximum Concentration) for Digoxin in Plasma
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.
Time frame: At designated timepoints (up to 5 days)
Terminal half life (T½) for Digoxin in Plasma
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.
Time frame: At designated timepoints (up to 5 days)
Apparent Clearance (CL/F) for Digoxin in Plasma
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.
Time frame: At designated timepoints (up to 5 days)
Apparent Volume of Distribution During Terminal Phase (Vz/F) for Digoxin in Plasma
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.
Time frame: At designated timepoints (up to 5 days)
Number of Participants With Treatment Emergent Adverse Events (TEAEs):
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.
Time frame: Up to ~ 28 days.
Number of Participants With Clinical Laboratory Abnormalities
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.
Time frame: Up to ~ 28 days
Standard and Orthostatic Vital Signs
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.
Time frame: Up to ~ 28 days
12-lead Electrocardiogram (ECGs)
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.
Time frame: Up to ~ 28days
Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Merck Sharp & Dohme LLC