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Healthy Female AdultsPhase 1NCT07800897

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

A Phase 1 study testing Navlimetostat, Itraconazole and Rifampin in people with Healthy Female Adults, run by Bristol-Myers Squibb at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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 Read more about this study

Who is it for?
Ages 18 to 55 years, women onlyHealthy volunteers can take part
Conditions the study is for
Healthy Female Adults
What is being tested?
Navlimetostat, Itraconazole and Rifampin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteCanada
Study dates
31 Aug 2026to 25 Mar 2027
Phase
Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

Canada1 site, 1 recruiting

  • Syneos Health Clinique; Inc.

    Québec, Quebec, G1P 0A2

    Lidia Facchinelli, Site 0001

    Recruiting

Other trials in Canada

About this study

Official title: 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

Being tested
Navlimetostat, Itraconazole, Rifampin, Midazolam, Pantoprazole
Keywords
PRMT5, MTAP, MRTX1719, MountainTAP, Healthy Adult Female, Individuals not of childbearing potential, Open Label Study, Clinical Research Unit, Phase 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NavlimetostatDrug

    Also called BMS-986504, MRTX-1719

    Specified dose on specified days

  • ItraconazoleDrug

    Specified dose on specified days

  • RifampinDrug

    Specified dose on specified days

  • MidazolamDrug

    Specified dose on specified days

  • PantoprazoleDrug

    Specified dose on specified days

Study groups in NCT07800897
Study groupRoleWhat they receive
Part 1AExperimentalNot described
Receives: Drug: Navlimetostat; Drug: Itraconazole
Part 1BExperimentalNot described
Receives: Drug: Navlimetostat; Drug: Rifampin
Part 2ExperimentalNot described
Receives: Drug: Navlimetostat; Drug: Midazolam
Part 3ExperimentalNot described
Receives: Drug: Navlimetostat
Part 4ExperimentalNot described
Receives: Drug: Navlimetostat; Drug: Pantoprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum observed concentration (Cmax) of Navlimetostat

    Part 1A, Part 1B, Part 3, Part 4

    Measured: Up to approximately 3 weeks

  2. Area under the concentration-time curve from time zero to 192 hours (AUC(0-192)) of Navlimetostat

    Part 1A

    Measured: Up to approximately 3 weeks

  3. (AUC(INF)) of Navlimetostat with the coadministration of itraconazole

    Part 1A

    Measured: Up to approximately 3 weeks

  4. AUC(INF) of Navlimetostat without the coadministration of itraconazole

    Part 1A

    Measured: Up to approximately 3 weeks

  5. 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

    Measured: Up to approximately 3 weeks

  6. AUC(INF) of Navlimetostat with the coadministration of Rifampin

    Part 1B

    Measured: Up to approximately 3 weeks

  7. AUC(INF) of Navlimetostat without the coadministration of Rifampin

    Part 1B

    Measured: Up to approximately 3 weeks

  8. Cmax of Midazolam

    Part 2

    Measured: Up to approximately 3 weeks

  9. AUC(0-T) of Midazolam

    Part 2

    Measured: Up to approximately 3 weeks

  10. AUC(INF) of Midazolam with the coadministration of Navlimetostat

    Part 2

    Measured: Up to approximately 3 weeks

  11. AUC(INF) of Midazolam without the coadministration of Navlimetostat

    Part 2

    Measured: Up to approximately 3 weeks

  12. AUC(INF) of Navlimetostat with a high fat meal

    Part 3

    Measured: Up to approximately 3 weeks

  13. AUC(INF) of Navlimetostat without a high fat meal

    Part 3

    Measured: Up to approximately 3 weeks

  14. AUC(INF) of Navlimetostat with the coadministration of Pantoprazole

    Part 4

    Measured: Up to approximately 3 weeks

  15. AUC(INF) of Navlimetostat without the coadministration of Pantoprazole

    Part 4

    Measured: Up to approximately 3 weeks

  16. Drug-related AEs

    Measured: Up to approximately 6 weeks

Secondary outcomes (41)

  1. Adverse events (AEs)

    Measured: Up to approximately 6 weeks

  2. Serious adverse events (SAEs)

    Measured: Up to approximately 6 weeks

  3. AEs leading to discontinuation of study or study intervention

    Measured: Up to approximately 6 weeks

  4. Number of participants with clinically significant changes in physical examination (PE)

    Measured: Up to approximately 6 weeks

  5. Number of participants with clinically significant changes in vital signs (VS)

    Measured: Up to approximately 6 weeks

  6. Number of participants with clinically significant changes in 12-lead electrocardiograms (ECGs)

    Measured: Up to approximately 6 weeks

  7. Number of participants with clinically significant changes in clinical laboratory test results

    Measured: Up to approximately 6 weeks

  8. AUC(0-T) of Navlimetostat

    Part 1A

    Measured: Up to approximately 3 weeks

  9. Time of maximum observed concentration (Tmax) of Navlimetostat

    Part 1A, Part 1B, Part 3, Part 4

    Measured: Up to approximately 3 weeks

  10. Half-life (T-HALF) of Navlimetostat

    Part 1A, Part 1B, Part 3, Part 4

    Measured: Up to approximately 3 weeks

  11. Apparent total body clearance (CLT/F) of Navlimetostat

    Part 1A, Part 1B, Part 3, Part 4

    Measured: Up to approximately 3 weeks

  12. Apparent volume of distribution at terminal phase (Vz/F) of Navlimetostat

    Part 1A, Part 1B, Part 3, Part 4

    Measured: Up to approximately 3 weeks

  13. Tmax of Midazolam

    Part 2

    Measured: Up to approximately 3 weeks

  14. T-HALF of Midazolam

    Part 2

    Measured: Up to approximately 3 weeks

  15. CLT/F of Midazolam

    Part 2

    Measured: Up to approximately 3 weeks

  16. Vz/F of Midazolam

    Part 2

    Measured: Up to approximately 3 weeks

  17. Cmax of Navlimetostat Metabolite

    Measured: Up to approximately 3 weeks

  18. AUC(0-T) of Navlimetostat Metabolite

    Measured: Up to approximately 3 weeks

  19. AUC(INF) of Navlimetostat Metabolite

    Measured: Up to approximately 3 weeks

  20. AUC(0-192) of Navlimetostat Metabolite

    Part 1A

    Measured: Up to approximately 3 weeks

  21. AUC(0-24) of Navlimetostat Metabolite

    Part 2

    Measured: Up to approximately 3 weeks

  22. Tmax of Navlimetostat Metabolite

    Measured: Up to approximately 3 weeks

  23. T-HALF of Navlimetostat Metabolite

    Measured: Up to approximately 3 weeks

  24. Mean ratio (MR)_Cmax of Navlimetostat Metabolite

    Measured: Up to approximately 3 weeks

  25. MR_AUC(0-T) of Navlimetostat Metabolite

    Measured: Up to approximately 3 weeks

  26. MR_AUC(INF) of Navlimetostat Metabolite

    Measured: Up to approximately 3 weeks

  27. MR_AUC(0-192) of Navlimetostat Metabolite

    Part 1A

    Measured: Up to approximately 3 weeks

  28. MR_AUC(0-24) of Navlimetostat Metabolite

    Part 2

    Measured: Up to approximately 3 weeks

  29. Cmax of Rifampin

    Part 1A and Part 1B

    Measured: Up to approximately 3 weeks

  30. Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) of Rifampin

    Part 1A and Part 1B

    Measured: Up to approximately 3 weeks

  31. Trough observed concentration (Ctrough) of Rifampin

    Part 1A and Part 1B

    Measured: Up to approximately 3 weeks

  32. Tmax of Rifampin

    Part 1A and Part 1B

    Measured: Up to approximately 3 weeks

  33. Cmax of 1-hydroxymidazolam

    Part 2

    Measured: Up to approximately 3 weeks

  34. AUC(0-T) of 1-hydroxymidazolam

    Part 2

    Measured: Up to approximately 3 weeks

  35. AUC(INF) of 1-hydroxymidazolam

    Part 2

    Measured: Up to approximately 3 weeks

  36. Tmax of 1-hydroxymidazolam

    Part 2

    Measured: Up to approximately 3 weeks

  37. T-HALF of 1-hydroxymidazolam

    Part 2

    Measured: Up to approximately 3 weeks

  38. MR_Cmax of 1-hydroxymidazolam

    Part 2

    Measured: Up to approximately 3 weeks

  39. MR_AUC(0-T) of 1-hydroxymidazolam

    Part 2

    Measured: Up to approximately 3 weeks

  40. MR_AUC(INF) of 1-hydroxymidazolam with the coadministration of Navlimetostat

    Part 2

    Measured: Up to approximately 3 weeks

  41. MR_AUC(INF) of 1-hydroxymidazolam without the coadministration of Navlimetostat

    Part 2

    Measured: Up to approximately 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2026
  2. Study start31 Aug 2026
  3. Primary completion25 Mar 2027 (estimated)
  4. Study completion25 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07800897
Sponsor's protocol ID
CA240-0050
Status last verified
Sep 2026
First submitted
28 Aug 2026
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

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