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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
2 formulations of SR419, SR419 suspension and SR419 capsule will be used in the study.
CMAX Clinical Research
Adelaide, Australia
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
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