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This study will consist of 2 parts. The study will evaluate whether administration of phenytoin impacts the single-dose drug levels of afimetoran and BMT-271199 (Part 1) and will evaluate whether multiple administrations of afimetoran impact the drug levels of midazolam and 1-hydroxymidazolam (Part 2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Afimetoran followed by phenytoin + afimetoran | Experimental |
| |
| Part 2: Midazolam followed by afimetoran + midazolam | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Afimetoran | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Parts 1 and 2 | Up to 53 days |
| Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T]) | Parts 1 and 2 | Up to 53 days |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) | Parts 1 and 2 | Up to 53 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to attain maximum observed plasma concentration (Tmax) | Parts 1 and 2 | Up to 53 days |
| Terminal half-life (T-Half) | Parts 1 and 2 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply.
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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 | Miami | Florida | 33136 | United States |
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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.html
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| ID | Term |
|---|---|
| D010672 | Phenytoin |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D006827 | Hydantoins |
| D048289 | Imidazolidines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 |
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|
| Phenytoin | Drug | Specified dose on specified days |
|
| Midazolam | Drug | Specified dose on specified days |
|
| Up to 53 days |
| Apparent total body clearance of the drug from the plasma (CLT/F) | Parts 1 and 2 | Up to 53 days |
| Number of participants with adverse events (AEs) | Parts 1 and 2 | Up to 124 days |
| Number of participants with clinical laboratory abnormalities | Parts 1 and 2 | Up to 66 days |
| Number of participants with physical examination abnormalities | Parts 1 and 2 | Up to 66 days |
| Number of participants with vital sign abnormalities | Parts 1 and 2 | Up to 66 days |
| Number of participants with electrocardiogram (ECG) abnormalities | Parts 1 and 2 | Up to 66 days |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |