A Phase 1 interventional study of SR419 in Healthy, sponsored by SIMR (Australia) Biotech Pty Ltd.. Completed at 1 site in Australia. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-25.
Sponsored by SIMR (Australia) Biotech Pty Ltd. · Phase 1, Interventional, and Treatment
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.
This is the only study on the registry with SIMR (Australia) Biotech Pty Ltd. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Each subject will be assigned to the fixed period sequence. * Period 1: SR419 suspension in the fasted state; * Period 2: SR419 capsule in the fasted state; * Period 3: SR419 capsule in the fed state (high-fat meal).
Drug: SR419
Each subject will receive 30 mg of SR419 capsule, once every 8 hours (Q8h), for 5 days.
Drug: SR419
2 formulations of SR419, SR419 suspension and SR419 capsule will be used in the study.
Peak plasma concentration of SR419
Time frame: Up to Day 12
Time of peak plasma concentration of SR419
Time frame: Up to Day 12
Area under the plasma concentration-time curve of SR419
Time frame: Up to Day 12
Apparent total clearance of SR419
Time frame: Up to Day 12
Terminal half-life of SR419
Time frame: Up to Day 12
Accumulation ratio of SR419
Time frame: Up to Day 12
Peak plasma concentration of SR419 metabolites
Time frame: Up to Day 12
Time of peak plasma concentration of SR419 metabolites
Time frame: Up to Day 12
Area under the plasma concentration-time curve of SR419 metabolites
Time frame: Up to Day 12
Terminal half-life of SR419 metabolites
Time frame: Up to Day 12
Accumulation ratio of SR419 metabolites
Time frame: Up to Day 12
Number of participants with adverse events
Time frame: Up to Day 15
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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