NCT02878096

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Sanwa Kagaku Kenkyusho Co., Ltd. · Industry
• Sex: Male
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

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

Detailed description

This is a single-centre, 2-part, open-label, non-randomised, sequential, single dose study in healthy male subjects. It is planned to enrol a single cohort of 6 healthy male subjects who will participate in Parts 1 and Part 2 of the study. In Part 1, each subject will receive a single PO dose of SK-1404 followed by an IV microtracer dose of \[14C\]-SK-1404. In Part 2, each subject will receive a single PO dose of \[14C\]-SK-1404.

Conditions

• Nocturia

Interventions

Type	Name	Description
DRUG	[14C]-SK-1404	In Part 1, each subject will receive a single PO dose of SK-1404 followed by an IV microtracer dose of \[14C\]-SK-1404.

Timeline

• Start date: 2016-07-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2016-08-25
• Last updated: 2016-10-14

Locations

1 site across 1 country: United Kingdom