Mass balance recovery study [14C]-SK-1405 in healthy Males (QCL117535)
Research type
Research Study
Full title
An Open-Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-SK-1405 Administered via the Oral Route to Healthy Male Subjects
IRAS ID
206379
Contact name
Kaori Taniko
Contact email
Sponsor organisation
SANWA KAGAKU KENKYUSHO (SKK) CO., LTD.
Eudract number
2016-001333-27
Duration of Study in the UK
0 years, 1 months, 0 days
Research summary
The Sponsor is developing the study drug, SK-1405, to treat the symptoms of long term itching (chronic pruritus). Chronic pruritus due to some conditions is very painful and can impact an individual’s quality of life. Pruritus is generally defined as an “uncomfortable sense causing desire to scratch".
The study will try to identify how radiolabelled SK-1405 is taken up, broken down and removed from the body when given orally (by mouth) as a solution. Radiolabelled means that the study drug has a radioactive component which helps researchers track where the drug is in the body.
This is a single period study involving up to 6 healthy male subjects. Each subject will receive a single dose of 10 mg of the study drug on one occasion. The study visit will last up to 15 days. Blood, urine and faeces samples will be collected from subjects at specific times throughout the study to look at the concentrations of the study drug and levels of radioactivity remaining in the body.
REC name
Wales REC 2
REC reference
16/WA/0185
Date of REC Opinion
5 Jul 2016
REC opinion
Further Information Favourable Opinion