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The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986521 following single and multiple ascending doses of BMS-986521 in healthy adult participants, and to evaluate potential food effects on BMS-986521 exposure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A Cohort 1 | Experimental |
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| Part A Cohort 2 | Experimental |
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| Part A Cohort 3 | Experimental |
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| Part A Cohort 4 | Experimental |
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| Part A Cohort 5 | Experimental |
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| Part A Cohort 6 | Experimental |
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| Part B Cohort 7 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-985521 | Drug | Specified dose on specified days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-emergent adverse events (AEs) | Up to approximately Day 40 | |
| Number of participants with treatment-emergent serious adverse events (SAEs) | Up to approximately Day 40 | |
| Number of participants with Treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to approximately Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Concentration (Cmax) of BMS-986521 in Plasma | Up to approximately Day 14 | |
| Time to Cmax (Tmax) of BMS-986521 in Plasma | Up to approximately Day 14 | |
| Area Under the Concentration-Time Curve from Time Zero to the Last Measured Time Point (AUC(0-T)) of BMS-986521 in Plasma |
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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 the NCT# and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CenExel ACT (Formerly Anaheim Clinical Trials; LLC) | Recruiting | Anaheim | California | 92801 | 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/disclosurecommitment.html
See Plan Description
See Plan Description
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| Part B Cohort 8 | Experimental |
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| Part B Cohort 9 | Experimental |
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| Part B Cohort 10 | Experimental |
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| Part B Cohort 11 | Experimental |
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| Part C | Experimental |
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| Placebo | Other | Specified dose on specified days |
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| Up to approximately Day 14 |
| Area Under the Concentration-Time Curve from Time Zero to 24 Hours (AUC(0-24)) of BMS-986521 in Plasma | Up to approximately Day 14 |
| Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC(INF)) of BMS-986521 in Plasma | Up to approximately Day 14 |
| Concentration Over a Dosing Interval (tau) (AUC(TAU)) of BMS-986521 in Plasma | Up to approximately Day 14 |
| Elimination Half-Life (T-HALF) of BMS-986521 in Plasma | Up to approximately Day 14 |
| Apparent Clearance of BMS-986521 from Plasma after Dosing (CLT/F) | Up to approximately Day 14 |
| Apparent Volume of Distribution in Plasma after Dosing (Vz/F) of BMS-986521 | Up to approximately Day 14 |
| Accumulation Index Based on Maximum Concentration (Cmax) in Plasma after Multiple Dosing (AI_Cmax) of BMS-986521 | Up to approximately Day 14 |
| Accumulation Index Based on Area Under the Curve (AUC) in Plasma After Multiple Dosing (AI_AUC) of BMS-986521 | Up to approximately Day 14 |
| Geometric Mean Cmax BMS-986521 under fed and fasted conditions | Cohort 3 | Up to approximately Day 11 |
| Geometric Mean AUC(0-T) BMS-986521 under fed and fasted conditions | Cohort 3 | Up to approximately Day 11 |
| Geometric Mean AUC(INF) BMS-986521 under fed and fasted conditions | Cohort 3 | Up to approximately Day 11 |
| Geometric mean ratios of Cmax for BMS-986521 oral tablet vs solution | Part C | Up to approximately Day 11 |
| Geometric mean ratios of AUC(0-T) for BMS-986521 oral tablet vs solution | Part C | Up to approximately Day 11 |
| Geometric mean ratios of AUC(INF) for BMS-986521 oral tablet vs solution | Part C | Up to approximately Day 11 |