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

ConditionHealthy Female Adults
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorBristol-Myers Squibb

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Sequential

Treatments tested in this trial

  • Navlimetostat

    Drug

    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

Treatment groups

80 Participants
are divided into 5 treatment groups
Group A: Part 1AExperimental treatment 2 interventions
Group B: Part 1BExperimental treatment 2 interventions
Group C: Part 2Experimental treatment 2 interventions
Group D: Part 3Experimental treatment 1 intervention
Group E: Part 4Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Maximum observed concentration (Cmax) of Navlimetostat

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

Time frame
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

Time frame
Up to approximately 3 weeks
3

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

Part 1A

Time frame
Up to approximately 3 weeks
4

AUC(INF) of Navlimetostat without the coadministration of itraconazole

Part 1A

Time frame
Up to approximately 3 weeks

Secondary outcomes

1

Adverse events (AEs)

Time frame
Up to approximately 6 weeks
2

Serious adverse events (SAEs)

Time frame
Up to approximately 6 weeks
3

AEs leading to discontinuation of study or study intervention

Time frame
Up to approximately 6 weeks
4

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

Time frame
Up to approximately 6 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bristol-Myers Squibb

Lead sponsor

Source ClinicalTrials.gov
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