This trial is completed!
Search for a recruiting clinical trial for your condition
Your journey
1What's a trial
2Find
3Review
4Get in touch
More info
You can access this
clinical trial
if you have
Nocturia
and you are
between 30 and 65
years old
1
This is an early phase trial to determine
the dosage and safety of the new treatment.
Show me locations

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