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A Study assessing the drug levels and drug effects of variable doses of BMS-986322 in Healthy Participants compared to a placebo. The study also assesses how BMS-986322 affects the body with food and its acidity levels.
Recruitment temporarily on hold due to COVID-19.
This is a randomized, double-blind, placebo-controlled study which will investigate the safety, tolerability, and PK of single and multiple oral doses of BMS-986322 in healthy subjects. The trial consists of three parts: Part A - a single ascending dose (SAD) safety and pharmacokinetic (PK) evaluation; Part B -a multiple ascending dose (MAD) safety, PK, and pharmacodynamic (PD) evaluation; and Part C - effect of food and pH on PK and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: BMS-986322 | Experimental |
| |
| Part B: BMS-986322 Placebo | Experimental |
| |
| Part C: BMS-986322 with famotidine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986322 | Drug | Specified Dose on Specified Days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Death | up to 12 months | |
| Incidence of Adverse Effects (AEs) | up to 12 months | |
| Incidence of Adverse Events leading to discontinuation | up to 12 months | |
| Incidence of Serious Adverse Events (SAEs) | up to 12 months | |
| Vital signs of body temperature | up to 12 months | |
| Vital signs of blood pressure | up to 12 months | |
| Vital signs of respiratory rate | up to 12 months | |
| Number of Participants with abnormal physical examinations | up to 12 months | |
| Number of clinically significant changes in Electrocardiograms (ECGs) | up to 12 months | |
| Number of clinically significant changes in lab assessment of blood serum | up to 12 months | |
| Number of clinically significant changes in lab assessment of urine | up to 12 months |
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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 |
|---|---|---|---|---|---|---|
| ICON (LPRA) - Lenexa | Lenexa | Kansas | 66219 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
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| ID | Term |
|---|---|
| D015738 | Famotidine |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| BMS-986322 Placebo | Other | Specified Dose on Specified Days |
|
| famotidine | Drug | Specified Dose on Specified Days |
|
| Number of Clinically significant changes in lab assessment of blood | up to 12 months |
| Maximum concentration (Cmax) of BMS-986322 in Part C | up to 12 months |
| Time of maximum concentration (Tmax) of BMS-986322 in Part C | up to 12 months |
| Terminal elimination rate constant (Lambda_z) of BMS-986322 in Part C | up to 12 months |
| Terminal elimination half-life (T-Half) of BMS-986322 in Part C | up to 12 months |
| Area under the plasma concentration-time curve extrapolated to infinity [AUC(INF)] of BMS-986322 in Part C | up to 12 months |
| Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration [AUC(0-T)] of BMS-986322 in Part C | up to 12 months |
| Apparent oral clearance (CL/F) of BMS-986322 in Part C | up to 12 months |
| Apparent volume of distrubution at terminal phase (Vz/F) of BMS-986322 in Part C | up to 12 months |
| FDA Safety Alerts and Recalls | View source |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |