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This is an open-label, randomized study to investigate the relative bioavailability of two formulations of BCX7353 and to determine if there is a food effect
In this study, 24 healthy subjects will be randomized to receive a single dose of two formulations of BCX7353 and one of the formulations administered with a high-fat meal. A 14-day washout period will separate each dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BCX7353 API in capsule | Experimental | fasted administration of BCX7353 API in capsule |
|
| BCX7353 blend in capsule | Experimental | fasted administration of BCX7353 blend in capsule |
|
| BCX7353 blend in capsule with food | Experimental | administration of BCX7353 blend in capsule following high-fat meal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCX7353 | Drug | BCX7353 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric least-squares mean ratio for Cmax for test (blend in capsule) versus reference formulation (API in capsule) | plasma pharmacokinetic parameters are based on blood sampling over a 72 hour period | |
| Geometric least-squares mean ratio for AUClast for test (blend in capsule) versus reference formulation (API in capsule) | plasma pharmacokinetic parameters are based on blood sampling over a 72 hour period | |
| Geometric least-squares mean ratio for AUCinf for test (blend in capsule) versus reference formulation (API in capsule) | plasma pharmacokinetic parameters are based on blood sampling over a 72 hour period | |
| Geometric least-squares mean ratio for Cmax for test (blend in capsule fed) versus reference formulation (blend in capsule fasted) | lasma pharmacokinetic parameters are based on blood sampling over a 72 hour period | |
| Geometric least-squares mean ratio for AUClast for test (blend in capsule fed) versus reference formulation (blend in capsule fasted) | lasma pharmacokinetic parameters are based on blood sampling over a 72 hour period | |
| Geometric least-squares mean ratio for AUCinf for test (blend in capsule fed) versus reference formulation (blend in capsule fasted) | lasma pharmacokinetic parameters are based on blood sampling over a 72 hour period |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | absolute and change from baseline through end of study, approximately 35 days | |
| laboratory analyses | absolute and change from baseline through end of study, approximately 35 days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Litza McKenzie, MBChB, BScMedSci | Quotient Clinical | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Clinical | Nottingham | NG11 6JS | United Kingdom |
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| ID | Term |
|---|---|
| D054179 | Angioedemas, Hereditary |
| ID | Term |
|---|---|
| D000799 | Angioedema |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000081208 | Hereditary Complement Deficiency Diseases |
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| ID | Term |
|---|---|
| C000706836 | berotralstat |
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Three way crossover to evaluate two formulations of BCX7353 and to determine if there is a food effect
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| vital signs |
| absolute and change from baseline through end of study, approximately 35 days |
| physical examination findings | absolute and change from baseline through end of study, approximately 35 days |
| electrocardiograms | absolute and change from baseline through end of study, approximately 35 days |
| D000081207 | Primary Immunodeficiency Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D007153 | Immunologic Deficiency Syndromes |