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| Name | Class |
|---|---|
| KCRN Research, LLC | INDUSTRY |
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Study to determine the effect of multiple-dose BBT-877 on the single-dose pharmacokinetics of midazolam, the safety and tolerability of a single dose of BBT-877 administered alone and with multiple doses of itraconazole, and the effect of multiple-dose esomeprazole on the single-dose pharmacokinetics of BBT-877, in healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midazolam | Experimental |
| |
| Itraconazole | Experimental |
| |
| Esomeprazole | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BBT-877 | Drug | BBT-877 oral capsule. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUC (the area under the curve) [Pharmacokinetics] | AUC for midazolam and 1-OH-midazolam with and without BBT-877 (Arm 1), and for BBT-877 with and without itraconazole (Arm 2) or esomeprazole (Arm 3) | Day 1 of period 1 and Day 10 (Arm 1), 5 (Arm 2), or 5 (Arm 3) of period 2 |
| Cmax (peak concentration) [Pharmacokinetics] | Cmax for midazolam and 1-OH-midazolam with and without BBT-877 (Arm 1), and for BBT-877 with and without itraconazole (Arm 2) or esomeprazole (Arm 3) | Day 1 of period 1 and Day 10 (Arm 1), 5 (Arm 2), or 5 (Arm 3) of period 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma LPA (Lysophosphatidic acid) concentration [Pharmacodynamics (Arm 2 and 3)] | plasma LPA (18:2 and 20:4) concentrations over time and percent decrease from baseline LPA level | Day 1 of period 1 and Day 10 (Arm 1), 5 (Arm 2), or 5 (Arm 3) of period 2 |
| Incidence of adverse events [Safety and tolerability] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeong-Hyun Ryou, M.D., Ph.D. | Bridge Biotherapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Lincoln | Nebraska | 68502 | United States |
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| ID | Term |
|---|---|
| C000723735 | ATX inhibitor BBT-877 |
| D008874 | Midazolam |
| D017964 | Itraconazole |
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Midazolam |
| Drug |
Midazolam oral syrup. |
|
| Itraconazole | Drug | Itraconazole oral capsule. |
|
| Esomeprazole | Drug | Esomeprazole oral capsule. |
|
Incidence of adverse events |
| Up to 14 days after the last study drug administration |
| D006571 | Heterocyclic Compounds |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D010879 | Piperazines |
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |