The primary objectives of the study are: * To determine the absolute bioavailability of SK-1404 * To assess the mass balance recovery after a single oral (PO) dose of carbon-14 (14C)-SK-1404 * To provide plasma, urine and faecal samples for metabolite profiling and structural identification The secondary objectives of the study are: * To determine the routes and rates of elimination of \[14C\]-SK-1404 * To identify the chemical structure of each metabolite with an exposure (AUC) of more than 10% of circulating total radioactivity * To explore the intravenous (IV) pharmacokinetics (PK) of \[14C\]-SK-1404 * To further explore the PO PK of SK-1404 * To provide additional safety and tolerability information for SK-1404
Age range
30 Years – 65 Years
Sex
MALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Absolute bioavailability (F) calculated with the AUC values of IV administration in Part 1 and PO administration in Part 2
Timeframe: Predose to 96hr
Mass balance recovery of total radioactivity in urine, faeces and all excreta
Timeframe: Predose to 168hr
Number and structural identification of known and unknown metabolites of SK-1404 in the plasma, urine and faeces samples
Timeframe: Predose to 168hr