A Clinical Trial of MK-4082 in Healthy Participants (MK-4082-005)
3. august 2026 opdateret af: Merck Sharp & Dohme LLC
A Clinical Study to Evaluate the Plasma Pharmacokinetics of a Single Dose of MK-4082 With and Without Diltiazem Coadministration in Healthy Participants
Researchers are looking for new weight loss medicines for people with higher body weight. The trial medicine, MK-4082, is different from similar weight loss medicines because people take it as a pill instead of an injection. Before giving a trial medicine to participants with a health condition, researchers first do trials in healthy participants to find a safe dose level (amount) of the trial medicine.
The goal of this study is to learn what happens to MK-4082 in a person's body over time. Researchers will compare what happens to levels of MK-4082 in people's blood when it is taken alone (Part 1, Period 1 and Part 2) and in combination with (Part 1, Period 2) another medicine called diltiazem. Researchers also want to learn about the safety of MK-4082 taken with and without diltiazem and if people tolerate them.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
28
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Toll Free Number
- Telefonnummer: 1-888-577-8839
- E-mail: Trialsites@msd.com
Studiesteder
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California
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Anaheim, California, Forenede Stater, 92801
- Rekruttering
- Anaheim Clinical Trials ( Site 0001)
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Kontakt:
- Study Coordinator
- Telefonnummer: 714-774-7777
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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
- Body mass index (BMI) between 18 and 32 kg/m^2, inclusive
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
- Has a history of previous surgical treatment for obesity that may induce malabsorption, history of bowel resection >20 cm, any malabsorption disorder, severe gastroparesis, or any GI procedure for weight loss
- Had a recent pancreatitis or has a history of pancreatitis
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: N/A
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: MK-4082
Participants will move sequentially through 2 periods in Part 1.
In Period 1, participants will receive a single oral dose of MK-4082 on Day 1.
In Period 2, participants will receive a single oral dose of MK-4082 on Day 1 plus oral diltiazem for multiple days.
In Part 2 participants receive a single dose of MK-4082 or placebo.
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Oral administration
Oral administration
All participants will receive ondansetron as a rescue medication.
Ondansetron is a medication used to prevent nausea or vomiting.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Part 1: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-∞) of MK-4082
Tidsramme: At designated timepoints (up to approximately 1 week postdose)
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Blood samples will be collected to determine the AUC0-∞ of MK-4082.
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At designated timepoints (up to approximately 1 week postdose)
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Part 1: Maximum Plasma Concentration (Cmax) of MK-4082
Tidsramme: At designated timepoints (up to approximately 1 week postdose)
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Blood samples will be collected to determine the Cmax of MK-4082.
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At designated timepoints (up to approximately 1 week postdose)
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Part 1: Number of Participants Who Experience an Adverse Event (AE)
Tidsramme: Up to approximately 31 days
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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 who experience an AE will be reported.
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Up to approximately 31 days
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Part 1: Number of Participants Who Discontinue Study Intervention Due to an AE
Tidsramme: Up to approximately 17 days
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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 who discontinue study intervention due to an AE will be reported.
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Up to approximately 17 days
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Part 2: AUC0-∞ of MK-4082
Tidsramme: At designated timepoints (up to approximately 1 week postdose)
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Blood samples will be collected to determine the AUC0-∞ of MK-4082.
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At designated timepoints (up to approximately 1 week postdose)
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Part 2: AUC0-24 of MK-4082
Tidsramme: At designated timepoints (up to 24 hours postdose)
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Blood samples will be collected to determine the AUC0-24 of MK-4082.
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At designated timepoints (up to 24 hours postdose)
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Part 2: Cmax of MK-4082
Tidsramme: At designated timepoints (up to approximately 1 week postdose)
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Blood samples will be collected to determine the Cmax of MK-4082.
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At designated timepoints (up to approximately 1 week postdose)
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Part 2: Time to maximum plasma concentration (Tmax) of MK-4082
Tidsramme: At designated timepoints (up to approximately 1 week postdose)
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Blood samples will be collected to determine the Tmax of MK-4082.
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At designated timepoints (up to approximately 1 week postdose)
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Part 2: Plasma concentration 24 hours postdose (C24) of MK-4082
Tidsramme: 24 hours postdose
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Blood samples will be collected to determine the C24 of MK-4082.
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24 hours postdose
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Part 2: Apparent terminal half-life (t½) of MK-4082
Tidsramme: At designated timepoints (up to approximately 1 week postdose)
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Blood samples will be collected to determine the t½ of MK-4082.
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At designated timepoints (up to approximately 1 week postdose)
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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 (Faktiske)
20. juli 2026
Primær færdiggørelse (Anslået)
28. september 2026
Studieafslutning (Anslået)
28. september 2026
Datoer for studieregistrering
Først indsendt
23. juni 2026
Først indsendt, der opfyldte QC-kriterier
10. juli 2026
Først opslået (Faktiske)
13. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 4082-005
- MK-4082-005 (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
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