Bioavailability of [14C]-SK-1404 ADME & IV Microtracer Study
Status:
Completed
Trial end date:
2016-08-01
Target enrollment:
Participant gender:
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