Clinical Trial: Bioavailability of [14C]-SK-1404 ADME & IV Microtracer Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Open-Label, 2-Part Sequential Dose Study Designed to Assess the Absolute Bioavailability, Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-SK-1404 Administered to He

Brief Summary:

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