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

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

Timeline

Start

2016-07

Primary completion

2016-08

Completion

2016-08

Drugs

Indications

No indication recorded.