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

Phase 1Not Yet RecruitingNCT07800897

Bristol-Myers Squibb80 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Female Adults

Interventions

NavlimetostatDRUG

Specified dose on specified days

ItraconazoleDRUG

Specified dose on specified days

RifampinDRUG

Specified dose on specified days

Midazolam

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Maximum observed concentration (Cmax) of Navlimetostat

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

Time frame: Up to approximately 3 weeks

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

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

Part 1A

Time frame: Up to approximately 3 weeks

AUC(INF) of Navlimetostat without the coadministration of itraconazole

Part 1A

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

Part 1B, Part 3, Part 4

Time frame: Up to approximately 3 weeks

AUC(INF) of Navlimetostat with the coadministration of Rifampin

Part 1B

Time frame: Up to approximately 3 weeks

AUC(INF) of Navlimetostat without the coadministration of Rifampin

Part 1B

Time frame: Up to approximately 3 weeks

Cmax of Midazolam

Part 2

Time frame: Up to approximately 3 weeks

AUC(0-T) of Midazolam

Part 2

Time frame: Up to approximately 3 weeks

Central Contacts

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

Data from ClinicalTrials.gov

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Secondary Outcomes

Adverse events (AEs)

Time frame: Up to approximately 6 weeks

Serious adverse events (SAEs)

Time frame: Up to approximately 6 weeks

AEs leading to discontinuation of study or study intervention

Time frame: Up to approximately 6 weeks

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

Time frame: Up to approximately 6 weeks

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

Time frame: Up to approximately 6 weeks

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

Time frame: Up to approximately 6 weeks

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

Time frame: Up to approximately 6 weeks

AUC(0-T) of Navlimetostat

Part 1A

Time frame: Up to approximately 3 weeks

Time of maximum observed concentration (Tmax) of Navlimetostat

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

Time frame: Up to approximately 3 weeks

Half-life (T-HALF) of Navlimetostat

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

Time frame: Up to approximately 3 weeks

Apparent total body clearance (CLT/F) of Navlimetostat

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

Time frame: Up to approximately 3 weeks

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

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

Time frame: Up to approximately 3 weeks

Tmax of Midazolam

Part 2

Time frame: Up to approximately 3 weeks

T-HALF of Midazolam

Part 2

Time frame: Up to approximately 3 weeks

CLT/F of Midazolam

Part 2

Time frame: Up to approximately 3 weeks

Vz/F of Midazolam

Part 2

Time frame: Up to approximately 3 weeks

Cmax of Navlimetostat Metabolite

Time frame: Up to approximately 3 weeks

AUC(0-T) of Navlimetostat Metabolite

Time frame: Up to approximately 3 weeks

AUC(INF) of Navlimetostat Metabolite

Time frame: Up to approximately 3 weeks

AUC(0-192) of Navlimetostat Metabolite

Part 1A

Time frame: Up to approximately 3 weeks

AUC(0-24) of Navlimetostat Metabolite

Part 2

Time frame: Up to approximately 3 weeks

Tmax of Navlimetostat Metabolite

Time frame: Up to approximately 3 weeks

T-HALF of Navlimetostat Metabolite

Time frame: Up to approximately 3 weeks

Mean ratio (MR)_Cmax of Navlimetostat Metabolite

Time frame: Up to approximately 3 weeks

MR_AUC(0-T) of Navlimetostat Metabolite

Time frame: Up to approximately 3 weeks

MR_AUC(INF) of Navlimetostat Metabolite

Time frame: Up to approximately 3 weeks

MR_AUC(0-192) of Navlimetostat Metabolite

Part 1A

Time frame: Up to approximately 3 weeks

MR_AUC(0-24) of Navlimetostat Metabolite

Part 2

Time frame: Up to approximately 3 weeks

Cmax of Rifampin

Part 1A and Part 1B

Time frame: Up to approximately 3 weeks

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

Part 1A and Part 1B

Time frame: Up to approximately 3 weeks

Trough observed concentration (Ctrough) of Rifampin

Part 1A and Part 1B

Time frame: Up to approximately 3 weeks

Tmax of Rifampin

Part 1A and Part 1B

Time frame: Up to approximately 3 weeks

Cmax of 1-hydroxymidazolam

Part 2

Time frame: Up to approximately 3 weeks

AUC(0-T) of 1-hydroxymidazolam

Part 2

Time frame: Up to approximately 3 weeks

AUC(INF) of 1-hydroxymidazolam

Part 2

Time frame: Up to approximately 3 weeks

Tmax of 1-hydroxymidazolam

Part 2

Time frame: Up to approximately 3 weeks

T-HALF of 1-hydroxymidazolam

Part 2

Time frame: Up to approximately 3 weeks

MR_Cmax of 1-hydroxymidazolam

Part 2

Time frame: Up to approximately 3 weeks

MR_AUC(0-T) of 1-hydroxymidazolam

Part 2

Time frame: Up to approximately 3 weeks

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

Part 2

Time frame: Up to approximately 3 weeks

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

Part 2

Time frame: Up to approximately 3 weeks