Recruiting
Phase 1

Navlimetostat

Sponsor:

Bristol-Myers Squibb

Code:

NCT07800897

Conditions

Healthy Female Adults

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Navlimetostat

Itraconazole

Rifampin

Midazolam

Pantoprazole

Study Details

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

Study ID

NCT07800897

Start date

Aug 31, 2026

Status verified date

Sep, 2026

Completion date

Mar 25, 2027

Anticipated

Primary completion date

Mar 25, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Accepted

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 Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1A

experimental: Part 1B

experimental: Part 2

experimental: Part 3

experimental: Part 4

Interventions

Navlimetostat

Specified dose on specified days

Itraconazole

Specified dose on specified days

Rifampin

Specified dose on specified days

Midazolam

Specified dose on specified days

Pantoprazole

Specified dose on specified days

Primary outcome measure

  • Maximum observed concentration (Cmax) of Navlimetostat [ Time Frame: Up to approximately 3 weeks ]
  • Area under the concentration-time curve from time zero to 192 hours (AUC(0-192)) of Navlimetostat [ Time Frame: Up to approximately 3 weeks ]
  • (AUC(INF)) of Navlimetostat with the coadministration of itraconazole [ Time Frame: Up to approximately 3 weeks ]
  • AUC(INF) of Navlimetostat without the coadministration of itraconazole [ Time Frame: 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 [ Time Frame: Up to approximately 3 weeks ]
  • AUC(INF) of Navlimetostat with the coadministration of Rifampin [ Time Frame: Up to approximately 3 weeks ]
  • AUC(INF) of Navlimetostat without the coadministration of Rifampin [ Time Frame: Up to approximately 3 weeks ]
  • Cmax of Midazolam [ Time Frame: Up to approximately 3 weeks ]
  • AUC(0-T) of Midazolam [ Time Frame: Up to approximately 3 weeks ]
  • AUC(INF) of Midazolam with the coadministration of Navlimetostat [ Time Frame: Up to approximately 3 weeks ]
  • AUC(INF) of Midazolam without the coadministration of Navlimetostat [ Time Frame: Up to approximately 3 weeks ]
  • AUC(INF) of Navlimetostat with a high fat meal [ Time Frame: Up to approximately 3 weeks ]
  • AUC(INF) of Navlimetostat without a high fat meal [ Time Frame: Up to approximately 3 weeks ]
  • AUC(INF) of Navlimetostat with the coadministration of Pantoprazole [ Time Frame: Up to approximately 3 weeks ]
  • AUC(INF) of Navlimetostat without the coadministration of Pantoprazole [ Time Frame: Up to approximately 3 weeks ]
  • Drug-related AEs [ Time Frame: Up to approximately 6 weeks ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

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

Locations

Syneos Health Clinique; Inc.

Recruiting

Québec, Quebec, Canada, G1P 0A2

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Oct 5, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-06. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-10-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.