Celerion ( Site 0001)
Lincoln, Nebraska, 68502, United States
NCT Number: NCT06597760
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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Notify Me19 year–55 year
All sexes
Interventional
Phase 1
Lincoln, Nebraska, 68502, United States
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:
Exclusion criteria
The key exclusion criteria include but are not limited to the following:
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
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
Merck Sharp & Dohme LLC
Industry
A Clinical Study to Evaluate the Effect of Enlicitide on the Pharmacokinetics of Digoxin in Healthy Adult Participants
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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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