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A Study of Navlimetostat (BMS-986504) Drug Interactions and Food Effect in Healthy Participants

30. September 2026 aktualisiert von: Bristol-Myers Squibb

A Phase 1, Open-label, Randomized, Pharmacokinetic Study to Assess the Drug Interactions and Food Effect of Navlimetostat (BMS-986504) in Healthy Female Participants

The purpose of this study is to assess the food effect and drug interactions on drug levels of Navlimetostat in health adult female participants

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

80

Phase

  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: First line of the email MUST contain NCT # and Site #.

Studieren Sie die Kontaktsicherung

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Telefonnummer: 855-907-3286
  • E-Mail: Clinical.Trials@bms.com

Studienorte

  • Kanada
    • Quebec
      • Québec, Quebec, Kanada, G1P 0A2
        • Rekrutierung
        • Syneos Health Clinique; Inc.
        • Kontakt:
          • Lidia Facchinelli, Site 0001

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

18 Jahre bis 55 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Weiblich

Beschreibung

Inclusion Criteria

  • Participants must be healthy adult female (as assigned at birth) individuals not of childbearing potential (INOCBP) who have no clinically significant findings on medical history, physical examination (PE), vital signs (VS), 12-lead electrocardiograms (ECGs), or clinical laboratory determinations, as assessed by the investigator.
  • Participants must have a BMI of 18.0 to 35.0 kg/m2, inclusive.

Exclusion Criteria

  • Participants must not have any significant acute or chronic medical illness (in the assessment of the investigator).
  • Participants must not have a history of prolonged bleeding or excessive bruising.
  • Participants must not have any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Studienplan

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

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Sequenzielle Zuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Teil 2
Arzneimittel: Navlimetostat

Specified dose on specified days

Andere Namen:
  • BMS-986504
  • MRTX-1719
Arzneimittel: Midazolam

Specified dose on specified days
Experimental: Teil 3
Arzneimittel: Navlimetostat

Specified dose on specified days

Andere Namen:
  • BMS-986504
  • MRTX-1719
Experimental: Teil 1A
Arzneimittel: Navlimetostat

Specified dose on specified days

Andere Namen:
  • BMS-986504
  • MRTX-1719
Arzneimittel: Itraconazole

Specified dose on specified days
Experimental: Teil 1B
Arzneimittel: Navlimetostat

Specified dose on specified days

Andere Namen:
  • BMS-986504
  • MRTX-1719
Arzneimittel: Rifampin

Specified dose on specified days
Experimental: Part 4
Arzneimittel: Navlimetostat

Specified dose on specified days

Andere Namen:
  • BMS-986504
  • MRTX-1719
Arzneimittel: Pantoprazole

Specified dose on specified days

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Drug-related AEs
Zeitfenster: Up to approximately 6 weeks
Up to approximately 6 weeks
Maximum observed concentration (Cmax) of Navlimetostat
Zeitfenster: Up to approximately 3 weeks

Part 1A, Part 1B, Part 3, Part 4
Up to approximately 3 weeks
Area under the concentration-time curve from time zero to 192 hours (AUC(0-192)) of Navlimetostat
Zeitfenster: Up to approximately 3 weeks

Part 1A
Up to approximately 3 weeks
(AUC(INF)) of Navlimetostat with the coadministration of itraconazole
Zeitfenster: Up to approximately 3 weeks

Part 1A
Up to approximately 3 weeks
AUC(INF) of Navlimetostat without the coadministration of itraconazole
Zeitfenster: Up to approximately 3 weeks

Part 1A
Up to approximately 3 weeks
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of Navlimetostat
Zeitfenster: Up to approximately 3 weeks

Part 1B, Part 3, Part 4
Up to approximately 3 weeks
AUC(INF) of Navlimetostat with the coadministration of Rifampin
Zeitfenster: Up to approximately 3 weeks

Part 1B
Up to approximately 3 weeks
AUC(INF) of Navlimetostat without the coadministration of Rifampin
Zeitfenster: Up to approximately 3 weeks

Part 1B
Up to approximately 3 weeks
Cmax of Midazolam
Zeitfenster: Up to approximately 3 weeks

Part 2
Up to approximately 3 weeks
AUC(0-T) of Midazolam
Zeitfenster: Up to approximately 3 weeks

Part 2
Up to approximately 3 weeks
AUC(INF) of Midazolam with the coadministration of Navlimetostat
Zeitfenster: Up to approximately 3 weeks

Part 2
Up to approximately 3 weeks
AUC(INF) of Midazolam without the coadministration of Navlimetostat
Zeitfenster: Up to approximately 3 weeks

Part 2
Up to approximately 3 weeks
AUC(INF) of Navlimetostat with a high fat meal
Zeitfenster: Up to approximately 3 weeks

Part 3
Up to approximately 3 weeks
AUC(INF) of Navlimetostat without a high fat meal
Zeitfenster: Up to approximately 3 weeks

Part 3
Up to approximately 3 weeks
AUC(INF) of Navlimetostat with the coadministration of Pantoprazole
Zeitfenster: Up to approximately 3 weeks

Part 4
Up to approximately 3 weeks
AUC(INF) of Navlimetostat without the coadministration of Pantoprazole
Zeitfenster: Up to approximately 3 weeks

Part 4
Up to approximately 3 weeks

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Adverse events (AEs)
Zeitfenster: Up to approximately 6 weeks
Up to approximately 6 weeks
Serious adverse events (SAEs)
Zeitfenster: Up to approximately 6 weeks
Up to approximately 6 weeks
AEs leading to discontinuation of study or study intervention
Zeitfenster: Up to approximately 6 weeks
Up to approximately 6 weeks
Number of participants with clinically significant changes in physical examination (PE)
Zeitfenster: Up to approximately 6 weeks
Up to approximately 6 weeks
Number of participants with clinically significant changes in vital signs (VS)
Zeitfenster: Up to approximately 6 weeks
Up to approximately 6 weeks
Number of participants with clinically significant changes in 12-lead electrocardiograms (ECGs)
Zeitfenster: Up to approximately 6 weeks
Up to approximately 6 weeks
Number of participants with clinically significant changes in clinical laboratory test results
Zeitfenster: Up to approximately 6 weeks
Up to approximately 6 weeks
Cmax of Navlimetostat Metabolite
Zeitfenster: Up to approximately 3 weeks
Up to approximately 3 weeks
AUC(0-T) of Navlimetostat Metabolite
Zeitfenster: Up to approximately 3 weeks
Up to approximately 3 weeks
AUC(INF) of Navlimetostat Metabolite
Zeitfenster: Up to approximately 3 weeks
Up to approximately 3 weeks
Tmax of Navlimetostat Metabolite
Zeitfenster: Up to approximately 3 weeks
Up to approximately 3 weeks
T-HALF of Navlimetostat Metabolite
Zeitfenster: Up to approximately 3 weeks
Up to approximately 3 weeks
Mean ratio (MR)_Cmax of Navlimetostat Metabolite
Zeitfenster: Up to approximately 3 weeks
Up to approximately 3 weeks
MR_AUC(0-T) of Navlimetostat Metabolite
Zeitfenster: Up to approximately 3 weeks
Up to approximately 3 weeks
MR_AUC(INF) of Navlimetostat Metabolite
Zeitfenster: Up to approximately 3 weeks
Up to approximately 3 weeks
AUC(0-T) of Navlimetostat
Zeitfenster: Up to approximately 3 weeks

Part 1A
Up to approximately 3 weeks
Time of maximum observed concentration (Tmax) of Navlimetostat
Zeitfenster: Up to approximately 3 weeks

Part 1A, Part 1B, Part 3, Part 4
Up to approximately 3 weeks
Half-life (T-HALF) of Navlimetostat
Zeitfenster: Up to approximately 3 weeks

Part 1A, Part 1B, Part 3, Part 4
Up to approximately 3 weeks
Apparent total body clearance (CLT/F) of Navlimetostat
Zeitfenster: Up to approximately 3 weeks

Part 1A, Part 1B, Part 3, Part 4
Up to approximately 3 weeks
Apparent volume of distribution at terminal phase (Vz/F) of Navlimetostat
Zeitfenster: Up to approximately 3 weeks

Part 1A, Part 1B, Part 3, Part 4
Up to approximately 3 weeks
Tmax of Midazolam
Zeitfenster: Up to approximately 3 weeks

Part 2
Up to approximately 3 weeks
T-HALF of Midazolam
Zeitfenster: Up to approximately 3 weeks

Part 2
Up to approximately 3 weeks
CLT/F of Midazolam
Zeitfenster: Up to approximately 3 weeks

Part 2
Up to approximately 3 weeks
Vz/F of Midazolam
Zeitfenster: Up to approximately 3 weeks

Part 2
Up to approximately 3 weeks
AUC(0-192) of Navlimetostat Metabolite
Zeitfenster: Up to approximately 3 weeks

Part 1A
Up to approximately 3 weeks
AUC(0-24) of Navlimetostat Metabolite
Zeitfenster: Up to approximately 3 weeks

Part 2
Up to approximately 3 weeks
MR_AUC(0-192) of Navlimetostat Metabolite
Zeitfenster: Up to approximately 3 weeks

Part 1A
Up to approximately 3 weeks
MR_AUC(0-24) of Navlimetostat Metabolite
Zeitfenster: Up to approximately 3 weeks

Part 2
Up to approximately 3 weeks
Cmax of Rifampin
Zeitfenster: Up to approximately 3 weeks

Part 1A and Part 1B
Up to approximately 3 weeks
Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) of Rifampin
Zeitfenster: Up to approximately 3 weeks

Part 1A and Part 1B
Up to approximately 3 weeks
Trough observed concentration (Ctrough) of Rifampin
Zeitfenster: Up to approximately 3 weeks

Part 1A and Part 1B
Up to approximately 3 weeks
Tmax of Rifampin
Zeitfenster: Up to approximately 3 weeks

Part 1A and Part 1B
Up to approximately 3 weeks
Cmax of 1-hydroxymidazolam
Zeitfenster: Up to approximately 3 weeks

Part 2
Up to approximately 3 weeks
AUC(0-T) of 1-hydroxymidazolam
Zeitfenster: Up to approximately 3 weeks

Part 2
Up to approximately 3 weeks
AUC(INF) of 1-hydroxymidazolam
Zeitfenster: Up to approximately 3 weeks

Part 2
Up to approximately 3 weeks
Tmax of 1-hydroxymidazolam
Zeitfenster: Up to approximately 3 weeks

Part 2
Up to approximately 3 weeks
T-HALF of 1-hydroxymidazolam
Zeitfenster: Up to approximately 3 weeks

Part 2
Up to approximately 3 weeks
MR_Cmax of 1-hydroxymidazolam
Zeitfenster: Up to approximately 3 weeks

Part 2
Up to approximately 3 weeks
MR_AUC(0-T) of 1-hydroxymidazolam
Zeitfenster: Up to approximately 3 weeks

Part 2
Up to approximately 3 weeks
MR_AUC(INF) of 1-hydroxymidazolam with the coadministration of Navlimetostat
Zeitfenster: Up to approximately 3 weeks

Part 2
Up to approximately 3 weeks
MR_AUC(INF) of 1-hydroxymidazolam without the coadministration of Navlimetostat
Zeitfenster: Up to approximately 3 weeks

Part 2
Up to approximately 3 weeks

Mitarbeiter und Ermittler

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

Sponsor

Bristol-Myers Squibb

Ermittler

  • Studienleiter: Bristol-Myers Squibb, Bristol-Myers Squibb

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 (Tatsächlich)

31. August 2026

Primärer Abschluss (Geschätzt)

25. März 2027

Studienabschluss (Geschätzt)

25. März 2027

Studienanmeldedaten

Zuerst eingereicht

28. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

28. August 2026

Zuerst gepostet (Tatsächlich)

2. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

5. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CA240-0050

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD-Sharing-Zeitrahmen

See Plan Description

IPD-Sharing-Zugriffskriterien

See Plan Description

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • CSR

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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