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The purpose of this study is to assess the effect of multiple dose administrations of Omeprazole on the pharmacokinetics of BMS-986205.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-986205 + Omeprazole | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986205 | Drug | Participants will receive BMS-986205 on Days 1 and 15 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of BMS-986205 | Up to Day 29 | |
| Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)] of BMS-986205 | Up to Day 29 | |
| Area Under the Plasma Concentration-time Curve from Time Zero Extrapolated to Infinite Time [AUC(INF)] | Up to Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation | Up to Day 36 | |
| Number of Participants with Vital Sign Abnormalities | Up to Day 29 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonia Davidson, MD | PPD Development, LP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Phase I Clinic | Austin | Texas | 78744 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS clinical trial educational resource | View source |
| Investigator Inquiry Form |
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| ID | Term |
|---|---|
| C000630574 | linrodostat |
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| omeprazole |
| Drug |
Participants will receive omeprazole on Days 10 to 15 |
|
| Number of Participants with 12-lead Electrocardiogram (ECG) Abnormalities | Up to Day 29 |
| Number of Participants with Physical Examination Abnormalities | Up to Day 29 |
| Number of Participants with Clinical Laboratory Results Abnormalities | Up to Day 29 |
| FDA Safety Alerts and Recalls | View source |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |