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

28. august 2026 opdateret af: 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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Healthy Female Adults

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

Fase

Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

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

Undersøgelse Kontakt Backup

Navn: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Telefonnummer: 855-907-3286
E-mail: Clinical.Trials@bms.com

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

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Ikke-randomiseret
Interventionel model: Sekventiel tildeling
Maskning: Ingen (Åben etiket)

Antal våben

Våben og indgreb

Deltagergruppe / Arm	Intervention / Behandling
Eksperimentel: Del 2	Medicin: Midazolam Specificeret dosis på specificerede dage Medicin: Navlimetostat Specificeret dosis på specificerede dage Andre navne: BMS-986504 MRTX-1719
Eksperimentel: Del 3	Medicin: Navlimetostat Specificeret dosis på specificerede dage Andre navne: BMS-986504 MRTX-1719
Eksperimentel: Del 1A	Medicin: Itraconazol Specificeret dosis på specificerede dage Medicin: Navlimetostat Specificeret dosis på specificerede dage Andre navne: BMS-986504 MRTX-1719
Eksperimentel: Del 1B	Medicin: Rifampin Specificeret dosis på specificerede dage Medicin: Navlimetostat Specificeret dosis på specificerede dage Andre navne: BMS-986504 MRTX-1719
Eksperimentel: Part 4	Medicin: Navlimetostat Specificeret dosis på specificerede dage Andre navne: BMS-986504 MRTX-1719 Medicin: Pantoprazole Specified dose on specified days

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Maximum observed concentration (Cmax) of Navlimetostat Tidsramme: 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 Tidsramme: Up to approximately 3 weeks	Part 1A	Up to approximately 3 weeks
(AUC(INF)) of Navlimetostat with the coadministration of itraconazole Tidsramme: Up to approximately 3 weeks	Part 1A	Up to approximately 3 weeks
AUC(INF) of Navlimetostat without the coadministration of itraconazole Tidsramme: 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 Tidsramme: 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 Tidsramme: Up to approximately 3 weeks	Part 1B	Up to approximately 3 weeks
AUC(INF) of Navlimetostat without the coadministration of Rifampin Tidsramme: Up to approximately 3 weeks	Part 1B	Up to approximately 3 weeks
Cmax of Midazolam Tidsramme: Up to approximately 3 weeks	Part 2	Up to approximately 3 weeks
AUC(0-T) of Midazolam Tidsramme: Up to approximately 3 weeks	Part 2	Up to approximately 3 weeks
AUC(INF) of Midazolam with the coadministration of Navlimetostat Tidsramme: Up to approximately 3 weeks	Part 2	Up to approximately 3 weeks
AUC(INF) of Midazolam without the coadministration of Navlimetostat Tidsramme: Up to approximately 3 weeks	Part 2	Up to approximately 3 weeks
AUC(INF) of Navlimetostat with a high fat meal Tidsramme: Up to approximately 3 weeks	Part 3	Up to approximately 3 weeks
AUC(INF) of Navlimetostat without a high fat meal Tidsramme: Up to approximately 3 weeks	Part 3	Up to approximately 3 weeks
AUC(INF) of Navlimetostat with the coadministration of Pantoprazole Tidsramme: Up to approximately 3 weeks	Part 4	Up to approximately 3 weeks
AUC(INF) of Navlimetostat without the coadministration of Pantoprazole Tidsramme: Up to approximately 3 weeks	Part 4	Up to approximately 3 weeks
Drug-related AEs Tidsramme: Up to approximately 6 weeks		Up to approximately 6 weeks

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Adverse events (AEs) Tidsramme: Up to approximately 6 weeks		Up to approximately 6 weeks
Serious adverse events (SAEs) Tidsramme: Up to approximately 6 weeks		Up to approximately 6 weeks
AEs leading to discontinuation of study or study intervention Tidsramme: Up to approximately 6 weeks		Up to approximately 6 weeks
Number of participants with clinically significant changes in physical examination (PE) Tidsramme: Up to approximately 6 weeks		Up to approximately 6 weeks
Number of participants with clinically significant changes in vital signs (VS) Tidsramme: Up to approximately 6 weeks		Up to approximately 6 weeks
Number of participants with clinically significant changes in 12-lead electrocardiograms (ECGs) Tidsramme: Up to approximately 6 weeks		Up to approximately 6 weeks
Number of participants with clinically significant changes in clinical laboratory test results Tidsramme: Up to approximately 6 weeks		Up to approximately 6 weeks
AUC(0-T) of Navlimetostat Tidsramme: Up to approximately 3 weeks	Part 1A	Up to approximately 3 weeks
Time of maximum observed concentration (Tmax) of Navlimetostat Tidsramme: Up to approximately 3 weeks	Part 1A, Part 1B, Part 3, Part 4	Up to approximately 3 weeks
Half-life (T-HALF) of Navlimetostat Tidsramme: 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 Tidsramme: 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 Tidsramme: Up to approximately 3 weeks	Part 1A, Part 1B, Part 3, Part 4	Up to approximately 3 weeks
Tmax of Midazolam Tidsramme: Up to approximately 3 weeks	Part 2	Up to approximately 3 weeks
T-HALF of Midazolam Tidsramme: Up to approximately 3 weeks	Part 2	Up to approximately 3 weeks
CLT/F of Midazolam Tidsramme: Up to approximately 3 weeks	Part 2	Up to approximately 3 weeks
Vz/F of Midazolam Tidsramme: Up to approximately 3 weeks	Part 2	Up to approximately 3 weeks
Cmax of Navlimetostat Metabolite Tidsramme: Up to approximately 3 weeks		Up to approximately 3 weeks
AUC(0-T) of Navlimetostat Metabolite Tidsramme: Up to approximately 3 weeks		Up to approximately 3 weeks
AUC(INF) of Navlimetostat Metabolite Tidsramme: Up to approximately 3 weeks		Up to approximately 3 weeks
AUC(0-192) of Navlimetostat Metabolite Tidsramme: Up to approximately 3 weeks	Part 1A	Up to approximately 3 weeks
AUC(0-24) of Navlimetostat Metabolite Tidsramme: Up to approximately 3 weeks	Part 2	Up to approximately 3 weeks
Tmax of Navlimetostat Metabolite Tidsramme: Up to approximately 3 weeks		Up to approximately 3 weeks
T-HALF of Navlimetostat Metabolite Tidsramme: Up to approximately 3 weeks		Up to approximately 3 weeks
Mean ratio (MR)_Cmax of Navlimetostat Metabolite Tidsramme: Up to approximately 3 weeks		Up to approximately 3 weeks
MR_AUC(0-T) of Navlimetostat Metabolite Tidsramme: Up to approximately 3 weeks		Up to approximately 3 weeks
MR_AUC(INF) of Navlimetostat Metabolite Tidsramme: Up to approximately 3 weeks		Up to approximately 3 weeks
MR_AUC(0-192) of Navlimetostat Metabolite Tidsramme: Up to approximately 3 weeks	Part 1A	Up to approximately 3 weeks
MR_AUC(0-24) of Navlimetostat Metabolite Tidsramme: Up to approximately 3 weeks	Part 2	Up to approximately 3 weeks
Cmax of Rifampin Tidsramme: 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 Tidsramme: Up to approximately 3 weeks	Part 1A and Part 1B	Up to approximately 3 weeks
Trough observed concentration (Ctrough) of Rifampin Tidsramme: Up to approximately 3 weeks	Part 1A and Part 1B	Up to approximately 3 weeks
Tmax of Rifampin Tidsramme: Up to approximately 3 weeks	Part 1A and Part 1B	Up to approximately 3 weeks
Cmax of 1-hydroxymidazolam Tidsramme: Up to approximately 3 weeks	Part 2	Up to approximately 3 weeks
AUC(0-T) of 1-hydroxymidazolam Tidsramme: Up to approximately 3 weeks	Part 2	Up to approximately 3 weeks
AUC(INF) of 1-hydroxymidazolam Tidsramme: Up to approximately 3 weeks	Part 2	Up to approximately 3 weeks
Tmax of 1-hydroxymidazolam Tidsramme: Up to approximately 3 weeks	Part 2	Up to approximately 3 weeks
T-HALF of 1-hydroxymidazolam Tidsramme: Up to approximately 3 weeks	Part 2	Up to approximately 3 weeks
MR_Cmax of 1-hydroxymidazolam Tidsramme: Up to approximately 3 weeks	Part 2	Up to approximately 3 weeks
MR_AUC(0-T) of 1-hydroxymidazolam Tidsramme: Up to approximately 3 weeks	Part 2	Up to approximately 3 weeks
MR_AUC(INF) of 1-hydroxymidazolam with the coadministration of Navlimetostat Tidsramme: Up to approximately 3 weeks	Part 2	Up to approximately 3 weeks
MR_AUC(INF) of 1-hydroxymidazolam without the coadministration of Navlimetostat Tidsramme: Up to approximately 3 weeks	Part 2	Up to approximately 3 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bristol-Myers Squibb

Efterforskere

Studieleder: Bristol-Myers Squibb, Bristol-Myers Squibb

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)

26. august 2026

Primær færdiggørelse (Anslået)

25. marts 2027

Studieafslutning (Anslået)

25. marts 2027

Datoer for studieregistrering

Først indsendt

28. august 2026

Først indsendt, der opfyldte QC-kriterier

28. august 2026

Først opslået (Faktiske)

2. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

CA240-0050

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

IPD-planbeskrivelse

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

IPD-delingstidsramme

See Plan Description

IPD-delingsadgangskriterier

See Plan Description

IPD-deling Understøttende informationstype

STUDY_PROTOCOL
SAP
CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

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 .

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

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

Studieoversigt

Status

Betingelser

Intervention / Behandling

Undersøgelsestype

Tilmelding (Anslået)

Fase

Kontakter og lokationer

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal våben

Våben og indgreb

Deltagergruppe / Arm

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Efterforskere

Publikationer og nyttige links

Hjælpsomme links

Datoer for undersøgelser

Studer store datoer

Studiestart (Anslået)

Primær færdiggørelse (Anslået)

Studieafslutning (Anslået)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Faktiske)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

IPD-planbeskrivelse

IPD-delingstidsramme

IPD-delingsadgangskriterier

IPD-deling Understøttende informationstype

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Studerer et amerikansk FDA-reguleret enhedsprodukt