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More info
You can access this
clinical trial
if you have
and you are
between 30 and 65
years old
This is an early phase trial to determine
the dosage and safety of the new treatment.
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The purpose

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

Provided treatments

  • Drug: [14C]-SK-1404

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT02878096. The sponsor of the trial is Sanwa Kagaku Kenkyusho Co., Ltd. and it is looking for 6 volunteers for the current phase.
Official trial 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 Healthy Male Subjects