ADME Study of [14C]-S-600918 in Healthy Male Volunteers (QSC203293)
Research type
Research Study
Full title
A Phase I Study to Investigate the Absorption, Distribution, Metabolism and Excretion of [14C]-S-600918 Following Oral Dose Administration in Healthy Adult Male Subjects
IRAS ID
282288
Contact name
Akimasa Fukushi
Contact email
Sponsor organisation
Shionogi B.V.
Eudract number
2020-001701-23
Duration of Study in the UK
0 years, 1 months, 13 days
Research summary
The Sponsor is developing the test medicine, S-600918, for the potential treatment of refractory chronic cough. Refractory chronic cough is defined as a chronic cough that continues after treatment for the disease(s) causing the cough or as an unexplained chronic cough for which the underlying disease has not been determined. The test medicine aims to block the mechanism thought to be responsible for stimulating the cough reflex.
The study involves radiolabelling (labelling the test medicine with radioactive 14C) which is used to locate the test medicine within the body. The study will try to assess how much radioactivity can be recovered from the urine and faeces (mass balance recovery) after a single oral dose of [14C]-S-600918. It will also look to identify the breakdown products (metabolites) of the parent drug. In addition it will aim to determine the rate and route of elimination of [14C]-S-600918, along with the level of test medicine in the blood (pharmacokinetics). The safety and tolerability of the test medicine will be assessed.
The study will consist of a one study period involving up to six healthy male volunteers. Volunteers will receive a single oral dose of 150 mg of the radiolabelled test medicine in the fasted state. Blood, urine and faecal samples will be collected whilst volunteers are resident at the clinical unit until 168 hours post-dose (Day 8) at the earliest. If the required level of radioactivity has not been recovered by this point, the residency period may be extended until 336 hours post-dose (Day 15) at the latest. If the required levels are still not recovered by Day 15 then additional home collections may be required.
REC name
HSC REC A
REC reference
20/NI/0081
Date of REC Opinion
3 Jul 2020
REC opinion
Favourable Opinion