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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Female Adults
• Intervention / Treatment: Drug: Itraconazole; Drug: Rifampin; Drug: Midazolam; Drug: Navlimetostat; Drug: Pantoprazole

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: First line of the email MUST contain NCT # and Site #.
• Study Contact Backup: Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 2	Drug: Midazolam; Specified dose on specified days; Drug: Navlimetostat; Specified dose on specified days; Other Names: BMS-986504; MRTX-1719
Experimental: Part 3	Drug: Navlimetostat; Specified dose on specified days; Other Names: BMS-986504; MRTX-1719
Experimental: Part 1A	Drug: Itraconazole; Specified dose on specified days; Drug: Navlimetostat; Specified dose on specified days; Other Names: BMS-986504; MRTX-1719
Experimental: Part 1B	Drug: Rifampin; Specified dose on specified days; Drug: Navlimetostat; Specified dose on specified days; Other Names: BMS-986504; MRTX-1719
Experimental: Part 4	Drug: Navlimetostat; Specified dose on specified days; Other Names: BMS-986504; MRTX-1719; Drug: Pantoprazole; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events (AEs)		Up to approximately 6 weeks
Serious adverse events (SAEs)		Up to approximately 6 weeks
AEs leading to discontinuation of study or study intervention		Up to approximately 6 weeks
Number of participants with clinically significant changes in physical examination (PE)		Up to approximately 6 weeks
Number of participants with clinically significant changes in vital signs (VS)		Up to approximately 6 weeks
Number of participants with clinically significant changes in 12-lead electrocardiograms (ECGs)		Up to approximately 6 weeks
Number of participants with clinically significant changes in clinical laboratory test results		Up to approximately 6 weeks
AUC(0-T) of Navlimetostat	Part 1A	Up to approximately 3 weeks
Time of maximum observed concentration (Tmax) of Navlimetostat	Part 1A, Part 1B, Part 3, Part 4	Up to approximately 3 weeks
Half-life (T-HALF) of Navlimetostat	Part 1A, Part 1B, Part 3, Part 4	Up to approximately 3 weeks
Apparent total body clearance (CLT/F) of Navlimetostat	Part 1A, Part 1B, Part 3, Part 4	Up to approximately 3 weeks
Apparent volume of distribution at terminal phase (Vz/F) of Navlimetostat	Part 1A, Part 1B, Part 3, Part 4	Up to approximately 3 weeks
Tmax of Midazolam	Part 2	Up to approximately 3 weeks
T-HALF of Midazolam	Part 2	Up to approximately 3 weeks
CLT/F of Midazolam	Part 2	Up to approximately 3 weeks
Vz/F of Midazolam	Part 2	Up to approximately 3 weeks
Cmax of Navlimetostat Metabolite		Up to approximately 3 weeks
AUC(0-T) of Navlimetostat Metabolite		Up to approximately 3 weeks
AUC(INF) of Navlimetostat Metabolite		Up to approximately 3 weeks
AUC(0-192) of Navlimetostat Metabolite	Part 1A	Up to approximately 3 weeks
AUC(0-24) of Navlimetostat Metabolite	Part 2	Up to approximately 3 weeks
Tmax of Navlimetostat Metabolite		Up to approximately 3 weeks
T-HALF of Navlimetostat Metabolite		Up to approximately 3 weeks
Mean ratio (MR)_Cmax of Navlimetostat Metabolite		Up to approximately 3 weeks
MR_AUC(0-T) of Navlimetostat Metabolite		Up to approximately 3 weeks
MR_AUC(INF) of Navlimetostat Metabolite		Up to approximately 3 weeks
MR_AUC(0-192) of Navlimetostat Metabolite	Part 1A	Up to approximately 3 weeks
MR_AUC(0-24) of Navlimetostat Metabolite	Part 2	Up to approximately 3 weeks
Cmax of Rifampin	Part 1A and Part 1B	Up to approximately 3 weeks
Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) of Rifampin	Part 1A and Part 1B	Up to approximately 3 weeks
Trough observed concentration (Ctrough) of Rifampin	Part 1A and Part 1B	Up to approximately 3 weeks
Tmax of Rifampin	Part 1A and Part 1B	Up to approximately 3 weeks
Cmax of 1-hydroxymidazolam	Part 2	Up to approximately 3 weeks
AUC(0-T) of 1-hydroxymidazolam	Part 2	Up to approximately 3 weeks
AUC(INF) of 1-hydroxymidazolam	Part 2	Up to approximately 3 weeks
Tmax of 1-hydroxymidazolam	Part 2	Up to approximately 3 weeks
T-HALF of 1-hydroxymidazolam	Part 2	Up to approximately 3 weeks
MR_Cmax of 1-hydroxymidazolam	Part 2	Up to approximately 3 weeks
MR_AUC(0-T) of 1-hydroxymidazolam	Part 2	Up to approximately 3 weeks
MR_AUC(INF) of 1-hydroxymidazolam with the coadministration of Navlimetostat	Part 2	Up to approximately 3 weeks
MR_AUC(INF) of 1-hydroxymidazolam without the coadministration of Navlimetostat	Part 2	Up to approximately 3 weeks

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Estimated): August 26, 2026
• Primary Completion (Estimated): March 25, 2027
• Study Completion (Estimated): March 25, 2027

Study Registration Dates

• First Submitted: August 28, 2026
• First Submitted That Met QC Criteria: August 28, 2026
• First Posted (Actual): September 2, 2026

Study Record Updates

• Last Update Posted (Actual): September 2, 2026
• Last Update Submitted That Met QC Criteria: August 28, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Phase 1; PRMT5; MTAP; Open Label Study; MRTX1719; MountainTAP; Individuals not of childbearing potential; Clinical Research Unit; Healthy Adult Female
• Additional Relevant MeSH Terms: 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Azoles; Polycyclic Compounds; Benzazepines; Heterocyclic Compounds, 4 or More Rings; Rifamycins; Lactams, Macrocyclic; Macrocyclic Compounds; Benzodiazepines; Triazoles; Piperazines; Pantoprazole; Midazolam; Rifampin; Itraconazole
• Other Study ID Numbers: CA240-0050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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 Sharing Time Frame: See Plan Description
• IPD Sharing Access Criteria: See Plan Description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No