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The purpose of this study is to evaluate safety, tolerability, drug and food effects on relative bioavailability of BMS-986465 and its active derivative BMS-986464 in healthy participants and healthy participants of Japanese ethnicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Single Ascending Dose (SAD) [BMS-986465 or placebo] | Experimental |
| |
| Part B: Multiple Ascending Dose (MAD) [BMS-986465 or placebo, Pegasys] | Experimental |
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| Part C: MAD in Japanese ethnicity [BMS-986465 or placebo] | Experimental |
| |
| Part D: Food/Formulation/pH Effects [BMS-986465, Famotidine] | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986465 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | Up to 28 days | |
| Incidence of serious adverse events (SAEs) | Up to 28 days | |
| Number of participants with vital sign abnormalities | Up to 28 days | |
| Number of participants with physical examination abnormalities | Up to 28 days | |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to 28 days | |
| Number of participants with clinical laboratory abnormalities | Up to 28 days | |
| Treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Up to Day 27 | |
| Time of maximum observed plasma concentration (Tmax) | Up to Day 27 | |
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol-defined inclusion/exclusion criteria apply
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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 | Anaheim | California | 92801 | United States | ||
| Local Institution - 0003 |
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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
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| Placebo | Other | Specified dose on specified days |
|
| Pegasys | Drug | Specified dose on specified days |
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| Famotidine | Drug | Specified dose on specified days |
|
| Up to Day 27 |
| Cerebrospinal fluid (CSF) concentrations | Up to Day 27 |
| Ratios of CSF to plasma concentrations | Up to 9 days |
| Austin |
| Texas |
| 78744 |
| United States |
| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
| D015738 | Famotidine |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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