ADME study of [14C]-S-033188 in healthy male volunteers (QCL117567)
Research type
Research Study
Full title
A phase 1 study to investigate the absorption, distribution, metabolism, and excretion of [14C] S 033188 following oral dose administration in healthy adult male subjects
IRAS ID
204017
Contact name
Yosuke Takeda
Contact email
Sponsor organisation
Shionoigi Limited
Eudract number
2016-001195-30
Duration of Study in the UK
0 years, 1 months, 12 days
Research summary
The Sponsor is developing the study drug, S-033188, for the potential treatment of the influenza virus (flu). Flu is an acute respiratory infection that spreads by droplet infection, symptoms include cold-like symptoms, fever, chills, headache, muscle aches and loss of appetite.
S-033188 is an anti-influenza drug with a novel mechanism of action. S-033188 is the inactive form of the drug which, once it enters the body, is converted to the active drug S-033447. This study is being conducted to further understand absorption, distribution, metabolism, and excretion (ADME) of radiolabelled S-033188 ([14C]-S-033188).
This is an open-label, single dose study in 6 healthy male adults. Subjects will receive a single 40 mg dose of [14C]-S-033188 as an oral suspension (liquid) in the fasted state. Blood, urine, and faecal samples will be collected at predefined selected time points up to a minimum of 288 hours post-dose to measure total radioactivity. Subjects will be discharged on the morning of Day 13 providing all subjects meet the discharge criteria. However, if any subject does not meet discharge criteria, all subjects will remain confined until either discharge criteria are met or until 408 hours post-dose procedures are completed, whichever occurs first. Subjects will be discharged as a group and not on an individual basis. If these criteria have not been met by all subjects at 408 hours post dose, home collections of urine and faeces may be requested at the discretion of the investigator for individual subjects. Subjects will return to the clinical research unit on Day 22 for a follow-up visit to ensure continued wellbeing.
REC name
Wales REC 2
REC reference
16/WA/0184
Date of REC Opinion
13 Jul 2016
REC opinion
Further Information Favourable Opinion