Recruiting
Phase 1

Navlimetostat

Sponsor:

Bristol-Myers Squibb

Code:

NCT07544628

Conditions

Healthy Participants

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Navlimetostat

Study Details

Brief summary:

This study aims to compare the PK of Navlimetostat after administration of a wet-granulation tablet versus the dry-granulation tablet formulation in healthy adult female

Conditions

Healthy Participants

Study ID

NCT07544628

Start date

Apr 27, 2026

Status verified date

Oct, 2026

Completion date

Nov 2, 2026

Anticipated

Primary completion date

Nov 2, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Participants must be healthy adult INOCBP female with no clinically significant findings on medical history, PE, VS, 12-lead ECGs, or clinical laboratory determinations, as assessed by the investigator.
  • Participants must have BMI of 18.0 to 35.0 kg/m2.
  • Participants must have adequate laboratory test results for renal and hepatic function, as assessed by the investigator, defined as eGFR ≥ 90 mL/min/1.73m2 using the CKD-EPI equation (screening only), and total bilirubin, ALP, GGT, AST, ALT ≤ 1.5 × ULN.

Exclusion Criteria:

  • Participant must not have any significant acute or chronic medical illness (in the assessment of the investigator).
  • Participant must not have current or recent GI disease: Any gastrointestinal disease within 3 months of study intervention administration that could possibly affect drug absorption, distribution, metabolism, and excretion (eg, bariatric procedure, history of pancreatitis, uncontrolled nausea or vomiting) in the opinion of the investigator.
  • Other protocol defined inclusion/exclusion criteria applies.

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment A

experimental: Treatment B

Interventions

Navlimetostat

Specified dose on specified days

Primary outcome measure

  • Maximum Plasma Concentration (Cmax) [ Time Frame: Up to Day 17 ]
  • Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] [ Time Frame: Up to Day 17 ]
  • Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] [ Time Frame: Up to Day 17 ]
  • Number of participants with Adverse Events (AE) [ Time Frame: Up to approximately day 37 ]
  • Number of participants with Serious Adverse Events (AE) [ Time Frame: Up to approximately day 37 ]
  • Number of participants with clinically significant changes in Physical Examinations (PE) [ Time Frame: Up to Day 17 ]
  • Number of participants with clinically significant changes in vital signs (VS) [ Time Frame: Up to Day 17 ]
  • Number of participants with clinically significant changes in 12-lead ECGs [ Time Frame: Up to Day 17 ]
  • Number of participants with clinically significant changes in laboratory tests results [ Time Frame: Up to Day 17 ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

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

Locations

CenExel iResearch - Decatur

Recruiting

Decatur, Georgia, United States, 30030

Contacts

Kimball Johnson, Site 0002

404-537-1281

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Oct 7, 2026

Last verified

Oct, 2026

Keywords

  • 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 2026-10-24. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-10-07. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.