This is a Phase 1, two-part, randomized, double blind, placebo controlled, ascending dose study to evaluate the safety, tolerability, pharmacokinetics of STI-1558 administered orally to healthy volunteers.
This is a Phase 1, two-part, randomized, double blind, placebo controlled, single ascending dose (Part 1) and multiple ascending dose (Part 2) study to evaluate the safety, tolerability, pharmacokinetics (PK) of STI-1558 administered orally to healthy volunteers. Part 1 of the study will also incorporate a single-cohort arm to investigate the effect of food on the PK of STI-1558. Dietary status of administration in part 2 (fasted or fed) will be determined by the PK data from Part 1. Part 2 may run in parallel with Part 1, providing that the total daily dose to be administered does not exceed a dose already shown to be safe and well-tolerated in Part 1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
58
Scientia Clinical Research Ltd
Randwick, New South Wales, Australia
Incidence of adverse events (AEs) (safety)
Safety as assessed by incidence of AEs by type, frequency, severity, and causality using the Common Terminology Criteria for Adverse Events, Version 5 (CTCAEv5) Safety as assessed by incidence of adverse events, clinically significant changes in safety lab results, physical exam, vital signs, and electrocardiogram
Time frame: baseline through study completion at up to 42 days
Cardiac function (safety)
Heart function as assessed by 12-lead electrocardiogram
Time frame: baseline through study completion at up to 42 days
AUC of STI-1558 (PK)
Area under the serum concentration-time curve (AUC) of STI-1558
Time frame: baseline through study completion at up to 42 days
Cmax of STI-1558
Maximum observed serum concentration (Cmax) of STI-1558
Time frame: baseline through study completion at up to 42 days
t1/2 of STI-1558
Apparent serum terminal elimination half life (t1/2) of STI-1558
Time frame: baseline through study completion at up to 42 days
Tmax of STI-1558
Time to Cmax (Tmax) of STI-1558
Time frame: baseline through study completion at up to 42 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.