A Phase 1, Open-label, Randomized, Pharmacokinetic Study to Assess the Drug Interactions and Food Effect of Navlimetostat (BMS-986504) in Healthy Female Participants
| Registry | NCT07800897 |
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| Status | Recruiting |
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| Phase | Phase 1 |
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| Study type | Interventional; non randomized, sequential, masking: none, treatment |
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| Enrollment | 80 (Estimated) |
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| Sponsor | Bristol-Myers Squibb (Industry) |
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| Conditions | Healthy Female Adults |
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| Interventions | Navlimetostat, Itraconazole, Rifampin, Midazolam, Pantoprazole (Drug) |
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| Dates | start 2026-08-31, primary completion 2027-03-25 (estimated), completion 2027-03-25 (estimated), first posted 2026-09-02, last updated 2026-10-05 |
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| Locations | 1 site in Canada |
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Related Papers Related Patents Related Grants Related Experts
All trials for Healthy Female Adults All trials of Navlimetostat All trials of Itraconazole
-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
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| 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 | |
- Navlimetostat (Drug), also known as BMS-986504, MRTX-1719: Specified dose on specified days
- Itraconazole (Drug): Specified dose on specified days
- Rifampin (Drug): Specified dose on specified days
- Midazolam (Drug): Specified dose on specified days
- Pantoprazole (Drug): Specified dose on specified days
+Outcome measures
Primary outcomes
- Maximum observed concentration (Cmax) of Navlimetostat [Up to approximately 3 weeks]: Part 1A, Part 1B, Part 3, Part 4
- Area under the concentration-time curve from time zero to 192 hours (AUC(0-192)) of Navlimetostat [Up to approximately 3 weeks]: Part 1A
- (AUC(INF)) of Navlimetostat with the coadministration of itraconazole [Up to approximately 3 weeks]: Part 1A
- AUC(INF) of Navlimetostat without the coadministration of itraconazole [Up to approximately 3 weeks]: Part 1A
- Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of Navlimetostat [Up to approximately 3 weeks]: Part 1B, Part 3, Part 4
- AUC(INF) of Navlimetostat with the coadministration of Rifampin [Up to approximately 3 weeks]: Part 1B
- AUC(INF) of Navlimetostat without the coadministration of Rifampin [Up to approximately 3 weeks]: Part 1B
- Cmax of Midazolam [Up to approximately 3 weeks]: Part 2
- AUC(0-T) of Midazolam [Up to approximately 3 weeks]: Part 2
- AUC(INF) of Midazolam with the coadministration of Navlimetostat [Up to approximately 3 weeks]: Part 2
- AUC(INF) of Midazolam without the coadministration of Navlimetostat [Up to approximately 3 weeks]: Part 2
- AUC(INF) of Navlimetostat with a high fat meal [Up to approximately 3 weeks]: Part 3
- AUC(INF) of Navlimetostat without a high fat meal [Up to approximately 3 weeks]: Part 3
- AUC(INF) of Navlimetostat with the coadministration of Pantoprazole [Up to approximately 3 weeks]: Part 4
- AUC(INF) of Navlimetostat without the coadministration of Pantoprazole [Up to approximately 3 weeks]: Part 4
- Drug-related AEs [Up to approximately 6 weeks]
Secondary outcomes
- 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 [Up to approximately 3 weeks]: Part 1A
- Time of maximum observed concentration (Tmax) of Navlimetostat [Up to approximately 3 weeks]: Part 1A, Part 1B, Part 3, Part 4
- Half-life (T-HALF) of Navlimetostat [Up to approximately 3 weeks]: Part 1A, Part 1B, Part 3, Part 4
- Apparent total body clearance (CLT/F) of Navlimetostat [Up to approximately 3 weeks]: Part 1A, Part 1B, Part 3, Part 4
- Apparent volume of distribution at terminal phase (Vz/F) of Navlimetostat [Up to approximately 3 weeks]: Part 1A, Part 1B, Part 3, Part 4
- Tmax of Midazolam [Up to approximately 3 weeks]: Part 2
- T-HALF of Midazolam [Up to approximately 3 weeks]: Part 2
- CLT/F of Midazolam [Up to approximately 3 weeks]: Part 2
- Vz/F of Midazolam [Up to approximately 3 weeks]: Part 2
- 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 [Up to approximately 3 weeks]: Part 1A
- AUC(0-24) of Navlimetostat Metabolite [Up to approximately 3 weeks]: Part 2
- 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 [Up to approximately 3 weeks]: Part 1A
- MR_AUC(0-24) of Navlimetostat Metabolite [Up to approximately 3 weeks]: Part 2
- Cmax of Rifampin [Up to approximately 3 weeks]: Part 1A and Part 1B
- Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) of Rifampin [Up to approximately 3 weeks]: Part 1A and Part 1B
- Trough observed concentration (Ctrough) of Rifampin [Up to approximately 3 weeks]: Part 1A and Part 1B
- Tmax of Rifampin [Up to approximately 3 weeks]: Part 1A and Part 1B
- Cmax of 1-hydroxymidazolam [Up to approximately 3 weeks]: Part 2
- AUC(0-T) of 1-hydroxymidazolam [Up to approximately 3 weeks]: Part 2
- AUC(INF) of 1-hydroxymidazolam [Up to approximately 3 weeks]: Part 2
- Tmax of 1-hydroxymidazolam [Up to approximately 3 weeks]: Part 2
- T-HALF of 1-hydroxymidazolam [Up to approximately 3 weeks]: Part 2
- MR_Cmax of 1-hydroxymidazolam [Up to approximately 3 weeks]: Part 2
- MR_AUC(0-T) of 1-hydroxymidazolam [Up to approximately 3 weeks]: Part 2
- MR_AUC(INF) of 1-hydroxymidazolam with the coadministration of Navlimetostat [Up to approximately 3 weeks]: Part 2
- MR_AUC(INF) of 1-hydroxymidazolam without the coadministration of Navlimetostat [Up to approximately 3 weeks]: Part 2
+Eligibility
Sex: Female, ages: 18 Years to 55 Years, accepts healthy volunteers
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.
+Locations (1)
| Facility | City | Country | Status |
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| Syneos Health Clinique; Inc. | Québec, Quebec | Canada | Recruiting |
+Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb