A Mass Balance Study of [14C]-S-217622 Oral Suspension in Healthy Adult Male Participants-QSC206321
Research type
Research Study
Full title
A Single-group, Phase 1, Open-label Study to Investigate the Absorption, Distribution, Metabolism and Excretion of [’4C]-S-217622 Following Oral Dose Administration as a Suspension in Healthy Adult Male Participants
IRAS ID
1005650
Contact name
Stephen Matthews
Contact email
Sponsor organisation
Shionogi B.V.
Eudract number
2022-000356-11
ISRCTN Number
ISRCTN90993148
Research summary
The Sponsor is developing a new test medicine for the potential treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2 / COVID-19) in patients. \nThe main symptoms of COVID-19 include a high temperature, a new continuous cough, a runny nose, a stuffy nose, sore throat, muscle aches, diarrhoea and a loss or change in your sense of smell and/or taste. Whilst the symptoms are similar to that of the common cold, COVID-19 can lead to more severe symptoms which may require hospitalisation in order to provide the patient with oxygen or mechanical ventilation. \nThis single-part, healthy volunteer study will try to identify how the test medicine is taken up, broken down and removed from the body. To help investigate this, the test medicine is radiolabelled, which means that the test medicine has a radioactive component (carbon-14) which helps us to track where the test medicine is in the body. The safety and tolerability of the test medicine will also be studied.\nThis study will take place at one non-NHS site, and will consist of a single study period involving up to 6 male volunteers, aged between 30 to 65 years. \nOn Day 1, volunteers will receive a single oral dose of the radiolabelled test medicine in the fasted state (on an empty stomach). \nVolunteer’s blood, urine and faeces will be taken throughout the study for analysis of the test medicine and its breakdown products (metabolites) and for volunteer safety. \nVolunteers will remain in the clinical unit until Day 15, however if the relevant radioactivity criteria have not been met, volunteers may be required to remain at the clinic until Day 22. If relevant criteria have not been met at this point, home collections of urine and/or faeces may be required. \nVolunteers are expected to be involved in this study for approximately 7 weeks from screening to discharge.
REC name
HSC REC A
REC reference
22/NI/0104
Date of REC Opinion
22 Jun 2022
REC opinion
Further Information Favourable Opinion