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

28. august 2026 oppdatert av: 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

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Healthy Female Adults

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

Fase

Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

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

Studer Kontakt Backup

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

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

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Behandling
Tildeling: Ikke-randomisert
Intervensjonsmodell: Sekvensiell tildeling
Masking: Ingen (Open Label)

Antall våpen

Våpen og intervensjoner

Deltakergruppe / Arm	Intervensjon / Behandling
Eksperimentell: Del 2	Legemiddel: Midazolam Spesifisert dose på angitte dager Legemiddel: Navlimetostat Spesifisert dose på spesifiserte dager Andre navn: BMS-986504 MRTX-1719
Eksperimentell: Del 3	Legemiddel: Navlimetostat Spesifisert dose på spesifiserte dager Andre navn: BMS-986504 MRTX-1719
Eksperimentell: Del 1A	Legemiddel: Itrakonazol Spesifisert dose på angitte dager Legemiddel: Navlimetostat Spesifisert dose på spesifiserte dager Andre navn: BMS-986504 MRTX-1719
Eksperimentell: Del 1B	Legemiddel: Rifampin Spesifisert dose på angitte dager Legemiddel: Navlimetostat Spesifisert dose på spesifiserte dager Andre navn: BMS-986504 MRTX-1719
Eksperimentell: Part 4	Legemiddel: Navlimetostat Spesifisert dose på spesifiserte dager Andre navn: BMS-986504 MRTX-1719 Legemiddel: Pantoprazole Specified dose on specified days

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	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	Tiltaksbeskrivelse	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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Bristol-Myers Squibb

Etterforskere

Studieleder: Bristol-Myers Squibb, Bristol-Myers Squibb

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 (Antatt)

26. august 2026

Primær fullføring (Antatt)

25. mars 2027

Studiet fullført (Antatt)

25. mars 2027

Datoer for studieregistrering

Først innsendt

28. august 2026

Først innsendt som oppfylte QC-kriteriene

28. august 2026

Først lagt ut (Faktiske)

2. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

CA240-0050

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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

Tilgangskriterier for IPD-deling

See Plan Description

IPD-deling Støtteinformasjonstype

STUDY_PROTOCOL
SEVJE
CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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

Studieoversikt

Status

Forhold

Intervensjon / Behandling

Studietype

Registrering (Antatt)

Fase

Kontakter og plasseringer

Studiekontakt

Studer Kontakt Backup

Deltakelseskriterier

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Tar imot friske frivillige

Beskrivelse

Studieplan

Hvordan er studiet utformet?

Designdetaljer

Antall våpen

Våpen og intervensjoner

Deltakergruppe / Arm

Intervensjon / Behandling

Hva måler studien?

Primære resultatmål

Resultatmål

Tiltaksbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Tiltaksbeskrivelse

Tidsramme

Samarbeidspartnere og etterforskere

Sponsor

Etterforskere

Publikasjoner og nyttige lenker

Hjelpsomme linker

Studierekorddatoer

Studer hoveddatoer

Studiestart (Antatt)

Primær fullføring (Antatt)

Studiet fullført (Antatt)

Datoer for studieregistrering

Først innsendt

Først innsendt som oppfylte QC-kriteriene

Først lagt ut (Faktiske)

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

Siste oppdatering sendt inn som oppfylte QC-kriteriene

Sist bekreftet

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

IPD-planbeskrivelse

IPD-delingstidsramme

Tilgangskriterier for IPD-deling

IPD-deling Støtteinformasjonstype

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Studerer et amerikansk FDA-regulert enhetsprodukt