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

NCT07800897 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: CA240-0050
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy Female Adults

Keywords

PRMT5; MTAP; MRTX1719; MountainTAP; Healthy Adult Female; Individuals not of childbearing potential; Open Label Study; Clinical Research Unit; Phase 1

Outcome Measures

Primary Outcomes (16)

• 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 Outcomes (41)

• 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

Study Arms (5)

Part 1A

EXPERIMENTAL

Drug: Navlimetostat; Drug: Itraconazole

Part 1B

EXPERIMENTAL

Drug: Navlimetostat; Drug: Rifampin

Part 2

EXPERIMENTAL

Drug: Navlimetostat; Drug: Midazolam

Part 3

EXPERIMENTAL

Drug: Navlimetostat

Part 4

EXPERIMENTAL

Drug: Navlimetostat; Drug: Pantoprazole

Interventions

Navlimetostat DRUG

Specified dose on specified days

Also known as: BMS-986504, MRTX-1719

Part 1A; Part 1B; Part 2; Part 3; Part 4

Itraconazole DRUG

Specified dose on specified days

Part 1A

Rifampin DRUG

Specified dose on specified days

Part 1B

Midazolam DRUG

Specified dose on specified days

Part 2

Pantoprazole DRUG

Specified dose on specified days

Part 4

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Female as assigned at birth.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Interventions

Itraconazole; Rifampin; Midazolam; Pantoprazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Benzimidazoles

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

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

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2026
• First Posted: September 2, 2026
• Study Start: August 26, 2026
• Primary Completion (Estimated): March 25, 2027
• Study Completion (Estimated): March 25, 2027
• Last Updated: September 2, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description