[14C]-SK-1404 ADME & IV Microtracer Study QCL117764
Research type
Research Study
Full 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.
IRAS ID
206892
Contact name
Yoshihiko Tagi
Contact email
Sponsor organisation
Sanwa Kagaku Kenkyusho (SKK) Co., Ltd.
Eudract number
2016-001351-45
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 26 days
Research summary
The Sponsor is developing the study drug SK-1404, to treat nocturia due to nocturnal polyuria (increase in urine production during the night). Nocturia has been reported to interfere with daily life activities resulting in decreased physical and mental quality of life, decreased activity, and lower productivity. The study will consist of two parts involving up to 6 healthy male subjects. Subjects will participate in both parts.
Part 1 of the study will investigate how SK-1404 (study drug) is taken up, broken down and removed from the body when given as a drink compared to when it is given as radiolabelled injection directly into the vein. 'Radiolabelled' means that the study drug has a radioactive component which helps researchers track where the drug is in the body.
Part 2 of the study will measure how radiolabelled SK-1404 is taken up, broken down and removed from the body when given as a drink. The safety and tolerability of the drug will also be assessed during both parts of the study.
SK-1404 aims to improve sleep and quality of life by reducing urine production through the night for an uninterrupted rest.
REC name
HSC REC A
REC reference
16/NI/0123
Date of REC Opinion
30 Jun 2016
REC opinion
Favourable Opinion