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The purpose of this study is to assess the safety, tolerability, drug levels, and relative bioavailability of alternate formulations of BMS-986460 in healthy adult male participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Sequence 1 | Experimental |
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| Part 1: Sequence 2 | Experimental |
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| Part 1: Sequence 3 | Experimental |
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| Part 2: Treatment A | Experimental |
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| Part 2: Treatment B | Experimental |
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| Part 2: Optional Treatment C | Experimental |
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| Part 2: Optional Treatment D | Experimental |
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| Part 2: Optional Treatment E |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986460 | Drug | Specified dose on specified days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of Participants With Adverse Events (AEs) | Up to approximately Day 43 | |
| Part 1: Number of Participants With Serious AEs (SAEs) | Up to approximately Day 43 | |
| Part 1: Number of Participants With Clinically Significant Physical Evaluation (PE) Findings | Up to approximately Day 21 | |
| Part 1: Number of Participants With Clinically Significant Vital Sign Abnormalities | Up to approximately Day 21 | |
| Part 1: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities | Up to approximately Day 21 | |
| Part 1: Number of Participants With Clinically Significant 12-lead Electrocardiogram (ECG) Findings | Up to approximately Day 21 | |
| Part 1: Maximum Observed Plasma Concentration (Cmax) of BMS-986460 | Up to approximately Day 21 | |
| Part 1: Time of Maximum Plasma Observed Concentration (Tmax) of BMS-986460 | Up to approximately Day 21 | |
| Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC [0-T]) of BMS-986460 | Up to approximately Day 21 | |
| Part 1: Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of BMS-986460 |
| Measure | Description | Time Frame |
|---|---|---|
| Part 2: Pharmacokinetic (PK) Linearity of BMS-986460 Based on Cmax | Up to approximately Day 7 | |
| Part 2: PK Linearity of BMS-986460 Based on AUC(0-T) | Up to approximately Day 7 | |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Lenexa | Kansas | 66219 | 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/disclosure-commitment.html
See plan description
See plan description
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|
| Up to approximately Day 21 |
| Part 1: Relative Bioavailability (rBA) of Alternate Formulations of BMS-986460 as Compared to Reference Formulation Based on Geometric Mean Ratio (GMR) of Cmax | Up to approximately Day 21 |
| Part 1: rBA of Alternate Formulations of BMS-986460 as Compared to Reference Formulation Based on GMR of AUC(0-T) | Up to approximately Day 21 |
| Part 1: rBA of Alternate Formulations of BMS-986460 as Compared to Reference Formulation Based on GMR of AUC(INF) | Up to approximately Day 21 |
| Part 2: Number of Participants With AEs | Up to approximately Day 29 |
| Part 2: Number of Participants With SAEs | Up to approximately Day 29 |
| Part 2: Number of Participants With Clinically Significant PE Findings | Up to approximately Day 7 |
| Part 2: Number of Participants With Clinically Significant Vital Sign Abnormalities | Up to approximately Day 7 |
| Part 2: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities | Up to approximately Day 7 |
| Part 2: Number of Participants With Clinically Significant 12-lead ECG Findings | Up to approximately Day 7 |
| Part 2: Cmax of BMS-986460 | Up to approximately Day 7 |
| Part 2: Tmax of BMS-986460 | Up to approximately Day 7 |
| Part 2: AUC [0-T] of BMS-986460 | Up to approximately Day 7 |
| Part 2: AUC(INF) of BMS-986460 | Up to approximately Day 7 |
| Part 2: PK Linearity of BMS-986460 Based on AUC(INF) |
| Up to approximately Day 7 |