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
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
Studientyp
Studientyp
Einschreibung (Geschätzt)
Einschreibung
Phase
Phase
- Phase 1
Kontakte und Standorte
Studienkontakt
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
Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
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
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Sequenzielle Zuweisung
- Maskierung: Keine (Offenes Etikett)
Anzahl der Arme
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
|---|---|
|
Experimental: Teil 2
|
Angegebene Dosis an bestimmten Tagen
Festgelegte Dosis an festgelegten Tagen
Andere Namen:
|
|
Experimental: Teil 3
|
Festgelegte Dosis an festgelegten Tagen
Andere Namen:
|
|
Experimental: Teil 1A
|
Angegebene Dosis an bestimmten Tagen
Festgelegte Dosis an festgelegten Tagen
Andere Namen:
|
|
Experimental: Teil 1B
|
Angegebene Dosis an bestimmten Tagen
Festgelegte Dosis an festgelegten Tagen
Andere Namen:
|
|
Experimental: Part 4
|
Festgelegte Dosis an festgelegten Tagen
Andere Namen:
Specified dose on specified days
|
Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
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
|
|
Drug-related AEs
Zeitfenster: Up to approximately 6 weeks
|
Up to approximately 6 weeks
|
Sekundäre Ergebnismessungen
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
|
|
|
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
|
|
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
|
|
|
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
|
|
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
|
|
|
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
Sponsor
Sponsor
Ermittler
Ermittler
- Studienleiter: Bristol-Myers Squibb, Bristol-Myers Squibb
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Studienbeginn
Primärer Abschluss (Geschätzt)
Primärer Abschluss
Studienabschluss (Geschätzt)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- 2-Pyridinylmethylsulfinylbenzimidazole
- Sulfoxide
- Schwefelverbindungen
- Organische Chemikalien
- Pyridinen
- Heterocyclische Verbindungen, 1-Ring
- Heterocyclische Verbindungen
- Benzimidazoles
- Heterocyclische Verbindungen, 2-Ring
- Heterocyclische Verbindungen, Fusionsring
- Azolen
- Polycyclische Verbindungen
- Benzazepines
- Heterocyclische Verbindungen, 4 oder mehr Ringe
- Rifamycins
- Lactams, makrocyclisch
- Makrocyclische Verbindungen
- Benzodiazepine
- Triazoles
- Piperazines
- Pantoprazol
- Midazolam
- Rifampin
- Itraconazol
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- CA240-0050
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
IPD-Sharing-Zeitrahmen
IPD-Sharing-Zugriffskriterien
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- CSR
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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