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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003100-51 | EudraCT Number |
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Assess the absolute bioavailability of a tablet formulation of BMS-986205 following simultaneous oral administration of BMS-986205 and intravenous infusion of [13C]BMS-986205 solution for intravenous administration in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-986205 | Experimental | Single oral dose of BMS-986205 tablet on the morning of Day 1 followed by a 15-minute infusion of [13C]BMS-986205 solution for intravenous administration starting 01:45 hours after the oral dose administration |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986205 | Drug | Specified Dose on Specified Days |
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| Measure | Description | Time Frame |
|---|---|---|
| Absolute oral bioavailability (F) | Measured by plasma concentration | Up to 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse events (AEs) | Safety and tolerability as measured by incidence of AEs | Up to 15 days |
| Occurrence of serious adverse events (SAEs) | Safety and tolerability as measured by incidence of SAEs |
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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 |
|---|---|---|---|---|---|---|
| Quotient Clinical | Nottingham | Ruddington Fields | NG11 6JS | United Kingdom |
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
| BMS Clinical Trial Information | View source |
| BMS clinical trial educational resource |
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| ID | Term |
|---|---|
| C000630574 | linrodostat |
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| Up to 15 days |
| Occurrence of adverse events (AEs) leading to discontinuation | Safety and tolerability as measured by incidence of AEs leading to discontinuation | Up to 15 days |
| Number of participants with vital sign measurement abnormalities | Up to 15 days |
| Number of participants with electrocardiogram abnormalities | Up to 15 days |
| Number of participants with physical examination abnormalities | Up to 15 days |
| Number of participants with clinical laboratory test abnormalities | Up to 15 days |