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

30 september 2026 uppdaterad 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

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

80

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

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

Studera Kontakt Backup

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

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 55 år (Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Kvinna

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Sekventiell tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Del 2
Läkemedel: Navlimetostat

Specified dose on specified days

Andra namn:
  • BMS-986504
  • MRTX-1719
Läkemedel: Midazolam

Specified dose on specified days
Experimentell: Del 3
Läkemedel: Navlimetostat

Specified dose on specified days

Andra namn:
  • BMS-986504
  • MRTX-1719
Experimentell: Del 1A
Läkemedel: Navlimetostat

Specified dose on specified days

Andra namn:
  • BMS-986504
  • MRTX-1719
Läkemedel: Itraconazole

Specified dose on specified days
Experimentell: Del 1B
Läkemedel: Navlimetostat

Specified dose on specified days

Andra namn:
  • BMS-986504
  • MRTX-1719
Läkemedel: Rifampin

Specified dose on specified days
Experimentell: Part 4
Läkemedel: Navlimetostat

Specified dose on specified days

Andra namn:
  • BMS-986504
  • MRTX-1719
Läkemedel: Pantoprazole

Specified dose on specified days

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Drug-related AEs
Tidsram: Up to approximately 6 weeks
Up to approximately 6 weeks
Maximum observed concentration (Cmax) of Navlimetostat
Tidsram: 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
Tidsram: Up to approximately 3 weeks

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

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

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

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

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

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

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

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

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

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

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

Part 4
Up to approximately 3 weeks

Sekundära resultatmått

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Part 2
Up to approximately 3 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Bristol-Myers Squibb

Utredare

  • Studierektor: Bristol-Myers Squibb, Bristol-Myers Squibb

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

31 augusti 2026

Primärt slutförande (Beräknad)

25 mars 2027

Avslutad studie (Beräknad)

25 mars 2027

Studieregistreringsdatum

Först inskickad

28 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

28 augusti 2026

Första postat (Faktisk)

2 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CA240-0050

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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

Tidsram för IPD-delning

See Plan Description

Kriterier för IPD Sharing Access

See Plan Description

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • CSR

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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