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This will be an open-label, single-site, Phase I study to evaluate the PK, safety, and tolerability of SR419 in healthy volunteers.
This study is a phase 1, open-label study to assess the single dose pharmacokinetics of suspension and capsule formulations of SR419 and repeat dose pharmacokinetics of capsule formulation of SR419, and to assess the effect of a high-fat meal on the pharmacokinetics of SR419 in healthy subjects.The trial will consist of 3 cohorts. Cohort 1 and 2 will follow a single sequence, 3-period, 2-formulation, dosing in fasted or fed state design. Cohort 3 will be a repeated dose study of SR419 capsule in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Dose Treatment | Experimental | Each subject will be assigned to the fixed period sequence.
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| Repeated Dose Treatment | Experimental | Each subject will receive 30 mg of SR419 capsule, once every 8 hours (Q8h), for 5 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SR419 | Drug | 2 formulations of SR419, SR419 suspension and SR419 capsule will be used in the study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration of SR419 | Up to Day 12 | |
| Time of peak plasma concentration of SR419 | Up to Day 12 | |
| Area under the plasma concentration-time curve of SR419 | Up to Day 12 | |
| Apparent total clearance of SR419 | Up to Day 12 | |
| Terminal half-life of SR419 | Up to Day 12 | |
| Accumulation ratio of SR419 | Up to Day 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration of SR419 metabolites | Up to Day 12 | |
| Time of peak plasma concentration of SR419 metabolites | Up to Day 12 | |
| Area under the plasma concentration-time curve of SR419 metabolites |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Polasek | CMAX Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMAX Clinical Research | Adelaide | 5000 | Australia |
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| Up to Day 12 |
| Terminal half-life of SR419 metabolites | Up to Day 12 |
| Accumulation ratio of SR419 metabolites | Up to Day 12 |
| Number of participants with adverse events | Up to Day 15 |