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The purpose of this study is to assess drug levels, tolerability and absolute biological availability of single subcutaneous dose of BMS-986446 in healthy participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental |
| |
| Arm B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986446 IV | Drug | Specified dose on specified days was administered intravenously (IV). |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Ratio (GMR) of Maximum Observed Serum Concentration (Cmax) of BMS-986446 Administered IV versus SC | Up to approximately Day 85 | |
| GMR of Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) of BMS-986446 Administered IV versus SC | Up to approximately Day 85 | |
| GMR of Area Under the Serum Concentration-time Curve From Time Zero to 672 Hours (AUC(0-672)) of BMS-986446 Administered IV versus SC | Up to approximately Day 85 | |
| Absolute Bioavailability (F) Estimated From GMR of AUC(INF) of BMS-986446 Administered as SC versus IV Infusion | Up to approximately Day 85 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | Up to approximately Day 85 | |
| Number of Participants With Serious Adverse Events (SAEs) | Up to approximately Day 85 | |
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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 | Anaheim | California | 92801 | United States | ||
| Local Institution - 10000 |
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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 Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.htm
See plan description
See plan description
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| BMS-986446 SC |
| Drug |
Specified dose on specified days was administered subcutaneously (SC). |
|
| Acetaminophen | Drug | Specified dose on specified days |
|
| Loratadine | Drug | Specified dose on specified days |
|
| Number of Participants With AEs Reported Related to BMS-986446 |
| Up to approximately Day 85 |
| Number of Participants With Clinically Significant Vital Sign Abnormalities | Up to approximately Day 85 |
| Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) | Up to approximately Day 85 |
| Number of Participants With Clinically Significant Physical Examination (PE) Abnormalities | Up to approximately Day 85 |
| Number of Participants With Suicidality as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to approximately Day 85 |
| Number of Participants With Clinically Significant Laboratory Assessment Abnormalities | Up to approximately Day 85 |
| Cmax of BMS-986446 | Up to approximately Day 85 |
| AUC(0-T) of BMS-986446 | Up to approximately Day 85 |
| AUC(0-672) of BMS-986446 | Up to approximately Day 85 |
| Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of BMS-986446 | Up to approximately Day 85 |
| Time of Maximum Observed Serum Concentration (Tmax) of BMS-986446 | Up to approximately Day 85 |
| Apparent Terminal Serum Half-life (T-HALF) of BMS-986446 | Up to approximately Day 85 |
| Total Body Clearance in IV Infusion (CLT) of BMS-986446 | Up to approximately Day 85 |
| Apparent Total Body Clearance in SC Administration (CLT/F) of BMS-986446 | Up to approximately Day 85 |
| Volume of Distribution of Terminal Phase in IV Infusion (Vz) of BMS-986446 | Up to approximately Day 85 |
| Apparent Volume of Distribution of Terminal Phase in SC Administration (Vz/F) of BMS-986446 | Up to approximately Day 85 |
| Number of Participants With Anti-drug Antibody Development | Up to approximately Day 85 |
| Local Tolerance Evaluation SC Administration of BMS-986646 Assessed by Questionnaire | Participant-reported response will be obtained using questionnaires that assess for pain (using a Numeric Rating Scale), itching, burning, pressure, and soreness/tenderness at the site injection. | Up to approximately Day 85 |
| Anaheim |
| California |
| 92801 |
| United States |
| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D017336 | Loratadine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D003533 | Cyproheptadine |
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
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