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

Nocturia Clinical Trial

Official 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

Status Completed

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Nocturia

• NCT number: NCT02878096
• Study type: Interventional
• Source: Sanwa Kagaku Kenkyusho Co., Ltd.
• Status: Completed
• Phase: Phase 1
• Start date: July 2016
• Completion date: August 2016