Trial · NCT06597760
A Clinical Study to Assess the Effect of Enlicitide on How the Body Processes Digoxin in Healthy Adult Participants (MK-0616-031)
NCT06597760, Phase 1, Completed, Merck Sharp & Dohme LLC
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Clinical Study to Assess the Effect of Enlicitide on How the Body Processes Digoxin in Healthy Adult Participants (MK-0616-031). Trials, record NCT06597760. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06597760
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Study to Assess the Effect of Enlicitide on How the Body Processes Digoxin in Healthy Adult Participants (MK-0616-031)
- NCT number
- NCT06597760
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 24 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Healthy
- Interventions
- Enlicitide, Digoxin
- First posted
- 2024-09-19
- Last updated
- 2024-11-29
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) for Digoxin in Plasma | 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 | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) for Digoxin in Plasma | 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). |
| Secondary | Cmax (Maximum Concentration) for Digoxin in Plasma | 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. |
| Secondary | Tmax (Time to Maximum Concentration) for Digoxin in Plasma | 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. |
| Secondary | Terminal half life (T½) for Digoxin in Plasma | 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. |
| Secondary | Apparent Clearance (CL/F) for Digoxin in Plasma | 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. |
| Secondary | Apparent Volume of Distribution During Terminal Phase (Vz/F) for Digoxin in Plasma | 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. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs): | 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. |
| Secondary | Number of Participants With Clinical Laboratory Abnormalities | 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. |
| Secondary | Standard and Orthostatic Vital Signs | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06597760
GET https://conductscience.org/api/trials/v1/NCT06597760/registered