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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental |
| |
| Treatment B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Navlimetostat | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) | Up to Day 17 | |
| Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] | Up to Day 17 | |
| Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] | Up to Day 17 | |
| Number of participants with Adverse Events (AE) | Up to approximately day 37 | |
| Number of participants with Serious Adverse Events (AE) | Up to approximately day 37 | |
| Number of participants with clinically significant changes in Physical Examinations (PE) | Up to Day 17 | |
| Number of participants with clinically significant changes in vital signs (VS) | Up to Day 17 | |
| Number of participants with clinically significant changes in 12-lead ECGs | Up to Day 17 | |
| Number of participants with clinically significant changes in laboratory tests results | Up to Day 17 |
| Measure | Description | Time Frame |
|---|---|---|
| Time of maximum observed drug concentration (Tmax) | Up to Day 17 | |
| Terminal elimination half-life (T-HALF) | Up to Day 17 | |
| Apparent total body clearance (CLT/F) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CenExel iResearch - Decatur | Recruiting | Decatur | Georgia | 30030 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
See Plan Description
See Plan Description
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| Up to Day 17 |
| Apparent volume of distribution during the terminal phase (Vz/F) | Up to Day 17 |
| Mean residence time (MRT) | Up to Day 17 |
| Local Institution - 0003 | Withdrawn | Decatur | Georgia | 30030 | United States |
| Local Institution - 0001 | Withdrawn | Austin | Texas | 78744 | United States |
| Local Institution - 0004 | Not yet recruiting | Austin | Texas | 78744 | United States |
|