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On hold to determine chosen formulations
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Single center, randomized, open label, two-part crossover study designed to evaluate the PK, food effect, dose proportionality, safety, and tolerability of BLD-2660 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tablet vs Capsule Formulation | Experimental | Single oral dose of BLD-2660 capsule or tablet formulation |
|
| Dose Proportionality | Experimental | Single oral dose of BLD-2660 tablet formulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BLD-2660 | Drug | Randomized to active product |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the drug concentration-time curve from time zero to the last measurable concentration (AUC0-last) | Measured by plasma concentration | Up to 40 days |
| AUC from time 0 to infinity (AUC0-inf) | Measured by plasma concentration | Up to 40 days |
| Maximum observed drug concentration (Cmax) | Measured by plasma concentration | Up to 40 days |
| Time of the maximum drug concentration (Tmax) | Measured by plasma concentration | Up to 40 days |
| Apparent terminal half-life (t½) | Measured by plasma concentration | Up to 40 days |
| Apparent terminal elimination rate constant (Kel) | Measured by plasma concentration | Up to 40 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | AEs will be assessed by determining the incidence, severity, and dose relationship of adverse events | Up to 40 days |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply.
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| Name | Affiliation | Role |
|---|---|---|
| Charlotte Lemech, MD | Scientia Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scientia Clinical Research | Randwick | New South Wales | 2031 | Australia |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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