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A Clinical Study of MK-8527 in Healthy Participants (MK-8527-021)

16. Juni 2026 aktualisiert von: Merck Sharp & Dohme LLC

An Open-label, Phase 1 Study to Individually Characterize the Food Effect, the Drug-Drug Interaction Effect of OAT Inhibition, and the Drug-Drug Interaction Effect of P-glycoprotein Inhibition on the Pharmacokinetics of MK-8527 in Healthy Adult Participants

Researchers are studying a medicine called MK-8527 to learn how it behaves in the body of healthy adults.

The goal of this study is to learn about the effect of MK-8527 when it is taken with food or with other medicines. Researchers also want to learn about the safety of MK-8527 and if people tolerate it. Tolerate means participants will receive treatment in the trial unless they need to stop it due to health problems.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

44

Phase

  • Phase 1

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

Inclusion Criteria:

  • Be in good health
  • Has a body mass index (BMI) between 18 and 32 kg/m^2, inclusive

Exclusion Criteria:

  • Has an estimated glomerular filtration rate (eGFR) ≤90 mL/min/1.73 m^2
  • Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
  • Has a history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair are allowed)
  • Has a history of cancer (malignancy)
  • Is taking any medication that contains emtricitabine (FTC) or lamivudine (3TC)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Grundlegende Wissenschaft
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Part 1: MK-8527
Participants will receive a single dose of MK-8527 with food and a single dose of MK-8527 without food.
Arzneimittel: MK-8527
Orale Tablette
Experimental: Part 2: MK-8527 + Probenecid
Participants will receive a single dose of MK-8527 alone and a single dose of MK-8527 in combination with probenecid.
Arzneimittel: MK-8527
Orale Tablette
Arzneimittel: Probenecid
Oral tablet
Experimental: Part 3: MK-8527 + Itraconazole
Participants will receive a single dose of MK-8527 alone and a single dose of MK-8527 in combination with itraconazole.
Arzneimittel: Itraconazol
Mündliche Lösung
Arzneimittel: MK-8527
Orale Tablette

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Part 1: Area Under the Concentration Time Curve From Time 0 to Infinity (AUC0-inf) of MK-8527 in Plasma With and Without Food
Zeitfenster: Predose and at designated timepoints (up to 336 hours postdose)
Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 in plasma.
Predose and at designated timepoints (up to 336 hours postdose)
Part 2: AUC0-inf of MK-8527 in Plasma With and Without Probenecid
Zeitfenster: Predose and at designated timepoints (up to 336 hours postdose)
Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 in plasma.
Predose and at designated timepoints (up to 336 hours postdose)
Part 3: AUC0-inf of MK-8527 in Plasma With and Without Itraconazole
Zeitfenster: Predose and at designated timepoints (up to 336 hours postdose)
Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 in plasma.
Predose and at designated timepoints (up to 336 hours postdose)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Part 1: Area Under the Concentration Time Curve From Time 0 to 336 Hours (AUC0-336) of MK-8527 in Plasma With and Without Food
Zeitfenster: Predose and at designated timepoints (up to 336 hours postdose)
Blood samples will be collected at multiple time points to estimate AUC0-336 of MK-8527 in plasma.
Predose and at designated timepoints (up to 336 hours postdose)
Part 1: Time to Maximum Plasma Concentration (Tmax) of MK-8527 in Plasma With and Without Food
Zeitfenster: Predose and at designated timepoints (up to 336 hours postdose)
Blood samples will be collected to estimate the Tmax of MK-8527 in plasma.
Predose and at designated timepoints (up to 336 hours postdose)
Part 1: Maximum Plasma Concentration (Cmax) of MK-8527 in Plasma With and Without Food
Zeitfenster: Predose and at designated timepoints (up to 336 hours postdose)
Blood samples will be collected to estimate the Cmax of MK-8527 in plasma.
Predose and at designated timepoints (up to 336 hours postdose)
Part 1: Apparent Terminal Half-life (t1/2) of MK-8527 in Plasma With and Without Food
Zeitfenster: Predose and at designated timepoints (up to 336 hours postdose)
Blood samples will be collected to estimate the apparent terminal t1/2 of MK-8527 in plasma.
Predose and at designated timepoints (up to 336 hours postdose)
Part 1: Number of Participants Who Experience an Adverse Event (AE)
Zeitfenster: Up to approximately 43 days
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience AE will be reported.
Up to approximately 43 days
Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE
Zeitfenster: Up to approximately 43 days
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Up to approximately 43 days
Part 2: AUC0-336 of MK-8527 in Plasma With and Without Probenecid
Zeitfenster: Predose and at designated timepoints (up to 336 hours postdose)
Blood samples will be collected to estimate the AUC0-336 of MK-8527 in plasma.
Predose and at designated timepoints (up to 336 hours postdose)
Part 2: Tmax of MK-8527 in Plasma with and without Probenecid
Zeitfenster: Predose and at designated timepoints (up to 336 hours postdose)
Blood samples will be collected to estimate the Tmax of MK-8527 in plasma.
Predose and at designated timepoints (up to 336 hours postdose)
Part 2: Cmax of MK-8527 in Plasma With and Without Probenecid
Zeitfenster: Predose and at designated timepoints (up to 336 hours postdose)
Blood samples will be collected to estimate the Cmax of MK-8527 in plasma.
Predose and at designated timepoints (up to 336 hours postdose)
Part 2: Apparent Terminal t1/2 of MK-8527 in Plasma With and Without Probenecid
Zeitfenster: Predose and at designated timepoints (up to 336 hours postdose)
Blood samples will be collected to estimate the apparent terminal t1/2 of MK-8527 in plasma.
Predose and at designated timepoints (up to 336 hours postdose)
Part 2: Urine Concentration at 72 Hours of MK-8527
Zeitfenster: At designated timepoints (up to 72 hours postdose)
Urine samples will be collected to estimate the urine concentration of MK-8527.
At designated timepoints (up to 72 hours postdose)
Part 2: Renal Clearance of MK-8527
Zeitfenster: At designated timepoints (up to 72 hours postdose)
Urine samples will be collected to estimate the renal clearance of MK-8527.
At designated timepoints (up to 72 hours postdose)
Part 2: Number of Participants Who Experience an AE
Zeitfenster: Up to approximately 43 days
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience AE will be reported.
Up to approximately 43 days
Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE
Zeitfenster: Up to approximately 43 days
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Up to approximately 43 days
Part 3: AUC0-336 of MK-8527 in Plasma With and Without Itraconazole
Zeitfenster: Predose and at designated timepoints (up to 336 hours postdose)
Blood samples will be collected at multiple time points to estimate AUC0-336 of MK-8527 in plasma.
Predose and at designated timepoints (up to 336 hours postdose)
Part 3: Tmax of MK-8527 in Plasma With and Without Itraconazole
Zeitfenster: Predose and at designated timepoints (up to 336 hours postdose)
Blood samples will be collected to estimate the Tmax of MK-8527 in plasma.
Predose and at designated timepoints (up to 336 hours postdose)
Part 3: Cmax of MK-8527 in Plasma With and Without Itraconazole
Zeitfenster: Predose and at designated timepoints (up to 336 hours postdose)
Blood samples will be collected to estimate the Cmax of MK-8527 in plasma.
Predose and at designated timepoints (up to 336 hours postdose)
Part 3: Apparent Terminal t1/2 of MK-8527 in Plasma With and Without Itraconazole
Zeitfenster: Predose and at designated timepoints (up to 336 hours postdose)
Blood samples will be collected to estimate the apparent t1/2 of MK-8527 in plasma.
Predose and at designated timepoints (up to 336 hours postdose)
Part 3: Urine Concentration at 72 Hours of MK-8527
Zeitfenster: At designated timepoints (up to 72 hours postdose)
Urine samples will be collected to estimate the urine concentration of MK-8527.
At designated timepoints (up to 72 hours postdose)
Part 3: Renal Clearance of MK-8527
Zeitfenster: At designated timepoints (up to 72 hours postdose)
Urine samples will be collected to estimate the renal clearance of MK-8527.
At designated timepoints (up to 72 hours postdose)
Part 3: Number of Participants Who Experience an AE
Zeitfenster: Up to approximately 43 days
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience AE will be reported.
Up to approximately 43 days
Part 3: Number of Participants Who Discontinue Study Treatment Due to an AE
Zeitfenster: Up to approximately 43 days
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Up to approximately 43 days

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Merck Sharp & Dohme LLC

Ermittler

  • Studienleiter: Medical Director, Merck Sharp & Dohme LLC

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

7. Juli 2026

Primärer Abschluss (Geschätzt)

9. Oktober 2026

Studienabschluss (Geschätzt)

9. Oktober 2026

Studienanmeldedaten

Zuerst eingereicht

16. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

16. Juni 2026

Zuerst gepostet (Tatsächlich)

22. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

22. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

16. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 8527-021
  • MK-8527-021 (Andere Kennung: MSD)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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