A Clinical Study of MK-7262 and Enlicitide in Healthy Participants (MK-7262-003)
27. maj 2026 opdateret af: Merck Sharp & Dohme LLC
A Clinical Drug-Drug Interaction Study to Evaluate the Mutual Pharmacokinetic Effects of MK-7262 and Enlicitide in Healthy Participants
The goal of this study is to learn what happens to a single dose of enlicitide over time in a healthy participant's body when the participant is given a single dose of MK-7262 and what happens to a single dose of MK-7262 over time in a healthy participant's body when the participant is given a single dose of enlicitide.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
30
Fase
- Fase 1
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inclusion Criteria:
The main 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 main exclusion criteria include but are not limited to the following:
- Has a history or presence of clinically significant medical or psychiatric condition or disease
- Has a history of cancer
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: MK-7262
Participants will receive MK-7262 orally.
|
Oral administration
|
|
Eksperimentel: Enlicitide
Participants will receive enlicitide orally.
|
Oral administration
Andre navne:
|
|
Eksperimentel: MK-7262 plus Enlicitide
Participants will receive MK-7262 and enlicitide orally.
|
Oral administration
Andre navne:
Oral administration
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MK-7262
Tidsramme: Predose and at designated time points post-dose (up to 8 days)
|
Blood samples will be collected at multiple time points to estimate the AUC0-inf of MK-7262.
|
Predose and at designated time points post-dose (up to 8 days)
|
|
AUC0-inf of Enlicitide
Tidsramme: Predose and at designated time points post-dose (up to 8 days post-dose)
|
Blood samples will be collected at multiple time points to estimate the AUC0-inf of enlicitide.
|
Predose and at designated time points post-dose (up to 8 days post-dose)
|
|
Maximum Plasma Concentration (Cmax) of MK-7262
Tidsramme: Predose and at designated time points post-dose (up to 8 days post-dose)
|
Blood samples will be collected at multiple time points to estimate the steady-state Cmax of MK-7262.
|
Predose and at designated time points post-dose (up to 8 days post-dose)
|
|
Cmax of Enlicitide
Tidsramme: Predose and at designated time points post-dose (up to 8 days post-dose)
|
Blood samples will be collected at multiple time points to estimate the steady-state Cmax of enlicitide.
|
Predose and at designated time points post-dose (up to 8 days post-dose)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Area Under the Concentration-Time Curve From Time 0 to 24 hours (AUC0-24) of MK-7262
Tidsramme: Predose and at designated time points post-dose (up to 24 hours post-dose)
|
Blood samples will be collected at multiple time points to estimate the AUC0-24 of MK-7262.
|
Predose and at designated time points post-dose (up to 24 hours post-dose)
|
|
Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of MK-7262
Tidsramme: Predose and at designated time points post-dose (up to 8 days post-dose)
|
Blood samples will be collected at multiple time points to estimate the AUC0-last of MK-7262.
|
Predose and at designated time points post-dose (up to 8 days post-dose)
|
|
Time to Maximum Plasma Concentration (Tmax) of MK-7262
Tidsramme: Predose and at designated time points post-dose (up to 8 days post-dose)
|
Blood samples will be collected at multiple time points to estimate the Tmax of MK-7262.
|
Predose and at designated time points post-dose (up to 8 days post-dose)
|
|
Apparent Terminal Half-life (t1/2) of MK-7262
Tidsramme: Predose and at designated time points post-dose (up to 8 days post-dose)
|
Blood samples will be collected at multiple time points to estimate the t1/2 of MK-7262.
|
Predose and at designated time points post-dose (up to 8 days post-dose)
|
|
Apparent Clearance (CL/F) of MK-7262
Tidsramme: Predose and at designated time points post-dose (up to 8 days post-dose)
|
Blood samples will be collected at multiple time points to estimate the CL/F of MK-7262.
|
Predose and at designated time points post-dose (up to 8 days post-dose)
|
|
Apparent Volume of Distribution During Terminal Phase (Vz/F)of MK-7262
Tidsramme: Predose and at designated time points post-dose (up to 8 days post-dose)
|
Blood samples will be collected at multiple time points to estimate the Vz/F of MK-7262.
|
Predose and at designated time points post-dose (up to 8 days post-dose)
|
|
AUC0-24 of Enlicitide
Tidsramme: Predose and at designated time points post-dose (up to 24 hours post-dose)
|
Blood samples will be collected at multiple time points to estimate the AUC0-24 of enlicitide.
|
Predose and at designated time points post-dose (up to 24 hours post-dose)
|
|
AUC0-last of Enlicitide
Tidsramme: Predose and at designated time points post-dose (up to 8 days post-dose)
|
Blood samples will be collected at multiple time points to estimate the AUC0-last of enlicitide.
|
Predose and at designated time points post-dose (up to 8 days post-dose)
|
|
Tmax of Enlicitide
Tidsramme: Predose and at designated time points post-dose (up to 8 days post-dose)
|
Blood samples will be collected at multiple time points to estimate the Tmax of enlicitide.
|
Predose and at designated time points post-dose (up to 8 days post-dose)
|
|
t1/2 of Enlicitide
Tidsramme: Predose and at designated time points post-dose (up to 8 days post-dose)
|
Blood samples will be collected at multiple time points to estimate the t1/2 of enlicitide.
|
Predose and at designated time points post-dose (up to 8 days post-dose)
|
|
CL/F of Enlicitide
Tidsramme: Predose and at designated time points post-dose (up to 8 days post-dose)
|
Blood samples will be collected at multiple time points to estimate the CL/F of enlicitide.
|
Predose and at designated time points post-dose (up to 8 days post-dose)
|
|
Vz/F of Enlicitide
Tidsramme: Predose and at designated time points post-dose (up to 8 days post-dose)
|
Blood samples will be collected at multiple time points to estimate the Vz/F of enlicitide.
|
Predose and at designated time points post-dose (up to 8 days post-dose)
|
|
Number of Participants Who Experience One or More Adverse Events (AEs)
Tidsramme: Up to approximately 8 weeks
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
The number of participants that experience AEs will be reported.
|
Up to approximately 8 weeks
|
|
Number of Participants Who Discontinue Study Due to an AE
Tidsramme: Up to approximately 6 weeks
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
The number of participants that discontinue study intervention due to an AE will be reported.
|
Up to approximately 6 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Medical Director, Merck Sharp & Dohme LLC
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
6. juli 2026
Primær færdiggørelse (Anslået)
5. september 2026
Studieafslutning (Anslået)
12. september 2026
Datoer for studieregistrering
Først indsendt
27. maj 2026
Først indsendt, der opfyldte QC-kriterier
27. maj 2026
Først opslået (Faktiske)
2. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 7262-003
- MK-7262-003 (Anden identifikator: MSD)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Enlicitid
-
Merck Sharp & Dohme LLCAfsluttetSund og raskForenede Stater
-
Merck Sharp & Dohme LLCRekrutteringSund og raskForenede Stater