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To assess the pharmacokinetics of 3 doses and the food effect of a single high dose of BBI-5000 capsules in healthy adult subjects.
This is an open-label, randomized, 4-period, 4-way crossover, 4-sequence study to evaluate the pharmacokinetics (PK) and food effect of BBI-5000 capsules in healthy adult subjects.
Participating subjects will receive a single oral dose of BBI-5000 followed by a washout period of 7-14 days between doses. The treatment period will be followed by 5-10 day follow-up period.
PK and PD will be assessed by blood sampling through 72 hours postdose.
Safety will be assessed through collection of vital signs, adverse events, physical examination, ECGs and clinical laboratory tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BBI-5000 Dose 1 | Experimental | Low dose of BBI-5000 |
|
| BBI-5000 Dose 2 | Experimental | Middle dose of BBI-5000 |
|
| BBI-5000 Dose 3 | Experimental | High dose of BBI-5000 |
|
| BBI-5000 Dose 4 | Experimental | High dose of BBI-5000 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BBI-5000 | Drug | BBI-5000 low dose, middle dose, or high doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations after single dosing of BBI-5000 for BBI-5000 and 3 metabolites | Week 4 | |
| Area Under Curve (AUC) for BBI-5000 and 3 metabolites | Week 4 | |
| Maximum Plasma Concentration (Cmax) for BBI-5000 and 3 metabolites | Week 4 | |
| Time of Occurrence of Cmax (Tmax) | Week 4 | |
| Clearance (CL/F) | Week 4 | |
| Terminal plasma elimination rate constant for BBI-5000 and the 3 metabolites | Week 4 | |
| BBI-5000 concentrations in plasma after dosing in fed and fasted conditions | Week 4 | |
| Half-life for BBI-5000 and the 3 metabolites | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability as measured by assessment of treatment-related adverse events, safety laboratory, vital signs, electrocardiogram and physical examination results | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Eosinophil shape change in whole blood as measured by dose and exposure-related dependent changes over time | Week 4 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Hussey, PharmD | Fresh Tracks Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion Inc. | Lincoln | Nebraska | 68502 | United States |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |