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The purpose of this study is to assess the safety and tolerability of BMS-986263 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-986263 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986263 | Drug | 3 weekly doses of 90 mg infused intravenous administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AE) | measured by incidences | 28 days |
| Serious Adverse Events (SAE) | measured by incidences | 30 days |
| Infusion related reactions | measured by incidences | 28 days |
| Abnormalities in clinical laboratory tests | measured by incidences | 28 days |
| Abnormal vital sign measurements | measured by incidences | 28 days |
| Abnormal electrocardiogram measurements | measured by incidences | 28 days |
| Physical examination abnormalities | measured by incidences | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum observed plasma concentration | 28 days |
| Tmax | Time of maximum observed plasma concentration | 28 days |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wcct Global, Llc | Cypress | California | 90630 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Patient Recruiting | View source |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004155 | Diphenhydramine |
| D015738 | Famotidine |
| ID | Term |
|---|---|
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D001559 | Benzhydryl Compounds |
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| Placebo |
| Other |
Placebo |
|
| Diphenhydramine | Drug | 50 mg intravenous administration |
|
| Famotidine | Drug | 20 mg intravenous administration |
|
| AUC(0-T) | Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration | 28 days |
| AUC(TAU) | Area under the concentration-time curve in one dosing interval (multiple dose only) | 28 days |
| T-HALF | Terminal phase half-life | 28 days |
| CLT | Total body clearance after IV dose | 28 days |
| AI_AUC | Accumulation Index, the ratio of AUC(TAU) at steady-state to that after the first dose (Day 15 only) | 28 days |
| T-HALFeff_AUC | Effective elimination half-life that explains the degree of accumulation observed for AUC(TAU) (Day 15 only) | 28 days |
| Ctrough | Trough observed plasma concentration | 28 days |
| Comparison of pharmacokinetic (PK) parameters in non-Japanese versus Japanese patients | Investigation of population specific differences in PK | 28 days |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |