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The purpose of the study is to assess the extent that radioactive dose of BCX4161 taken by mouth ends up in the urine, feces and expired air. If there are metabolites of BCX4161 made by the body, the chemical composition of these metabolites and their profile over time in blood and urine will be determined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C] BCX4161 | Experimental | Includes a radiolabelled dose of [14C] BCX4161 and unlabelled BCX4161 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCX4161 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mass balance of BCX4161 after a single oral dose of [14C] BCX4161 based upon radioactivity excreted in urine, expired air and feces | Determined from samples drawn up to 14 days post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Chemical structure elucidation of major metabolites of [14C] BCX4161 in urine, plasma, feces, urine | Determined from samples drawn up to 4 days post-dose | |
| Plasma pharmacokinetics (Cmax, Tmax, Tlag, AUC(0-last), AUC(0-inf), CL/F, Vz/F, AUC%extrapolated,t1/2, as applicable for each analyte) of total radioactivity, BCX4161, [14C] BCX4161 and major metabolites of [14C] BCX4161 |
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Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanne Collier, MBChB, FFPM, Dip Stats (OU) | Quotient Clinical Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Clinical Ltd | Ruddington | 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 |
|---|---|
| C000722673 | avoralstat |
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| Data generated from samples drawn up to 7 days post-dose |
| Urinary pharmacokinetics (CLr, Ae, and % dose excreted) of BCX4161 | Data generated from samples drawn up to 7 days post-dose |
| Safety and tolerability evaluated through assessments of adverse events, laboratory analyses, vital signs, ECGs, and physical examinations | Over the duration of the study, approximately 6 weeks from screening through follow-up |
| 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 |