A Clinical Study of MK-7262 and Enlicitide in Healthy Participants (MK-7262-003)
4. august 2026 oppdatert av: 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.
Studieoversikt
Status
Aktiv, ikke rekrutterende
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
30
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Nebraska
-
Lincoln, Nebraska, Forente stater, 68502
- Celerion ( Site 0001)
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske 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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: MK-7262
Participants will receive MK-7262 orally.
|
Oral administration
|
|
Eksperimentell: Enlicitide
Participants will receive enlicitide orally.
|
Oral administrering
Andre navn:
|
|
Eksperimentell: MK-7262 plus Enlicitide
Participants will receive MK-7262 and enlicitide orally.
|
Oral administrering
Andre navn:
Oral administration
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Medical Director, Merck Sharp & Dohme LLC
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. juli 2026
Primær fullføring (Antatt)
5. september 2026
Studiet fullført (Antatt)
12. september 2026
Datoer for studieregistrering
Først innsendt
27. mai 2026
Først innsendt som oppfylte QC-kriteriene
27. mai 2026
Først lagt ut (Faktiske)
2. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 7262-003
- MK-7262-003 (Annen identifikator: MSD)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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