Healthy Female Adults
Conditions
Keywords
PRMT5, MTAP, MRTX1719, MountainTAP, Healthy Adult Female, Individuals not of childbearing potential, Open Label Study, Clinical Research Unit, Phase 1
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
Interventions
DRUGNavlimetostat
Specified dose on specified days
DRUGItraconazole
Specified dose on specified days
DRUGRifampin
Specified dose on specified days
DRUGMidazolam
Specified dose on specified days
DRUGPantoprazole
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed