A Mass Balance Study of [14C]-S-3093 09 Oral Capsule in Healthy Adult Male Participants
Research type
Research Study
Full title
A Single-group, Phase 1, Open-label Study to Investigate the Absorption, Distribution, Metabolism and Excretion of [14C]S-309309 Following Oral Dose Administration as a Capsule in Healthy Adult Male Participants
IRAS ID
1007036
Contact name
Mia Hughes
Contact email
Sponsor organisation
Shionogi B.V.
Eudract number
2022-002263-30
ISRCTN Number
ISRCTN12615820
Research summary
Research Summary\n\nThe Sponsor is developing the test medicine, S-309309, for the potential treatment of obesity. When a person is overweight due to having a high amount of body fat, they are considered obese. Obesity is a complex disorder and can be associated with an increased risk of a person developing other conditions such as: hypertension (high blood pressure), type 2 diabetes, high cholesterol, cardiovascular (heart) disease, gallbladder disease, osteoarthritis (painful and stiff joints), sleep apnoea (where a person stops breathing in their sleep for short periods) and cancer.\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; also referred as 14C) 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, enrolling 6 male volunteers, aged between 30 and 65 years old.\nOn day 1, 6 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 their safety.\nVolunteers will remain in the clinical unit until Day 8, however if relevant radioactivity criteria have not been met, volunteers may be required to remain at the clinical unit until Day 15. 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 6 weeks from screening to discharge.\n\nSummary of Results\n\nIf yes - please enter the URL to summary results\tn/a\nIf no – why not?\t“A deferral to full clinical trial registration on a publicly accessible database and publication of a full research summary on the HRA research summaries database is currently in place.\nA minimal dataset is published on ISRCTN and the full study dataset will be published on ISRCTN once the deferral ends. A summary of results may not be published at the end of the deferral as this is an early phase trial in healthy volunteers, and as such, the results are commercially sensitive.“\nDid you follow your dissemination plan submitted in the IRAS application form (Q A51)?\tYes\nIf yes, describe or provide URLs to disseminated materials\tThe clinical trial report has been distributed to the regulatory authorities, in line with the dissemination plan. As this is a Phase I healthy volunteer study whose results are commercially sensitive, no further publications or presentations are currently planned.\nIf pending, date when dissemination is expected\tn/a\nIf no, explain why you didn’t follow it\tn/a\nHave participants been informed of the results of the study?\tNo\nIf yes, describe and/or provide URLs to materials shared and how they were shared\tn/a\nIf pending, date when feedback is expected\tn/a\nIf no, explain why they haven’t\tThe findings of this Phase I study are confidential owing to commercial sensitivity. Therefore, it is not appropriate to share the results of this study with volunteers at this time.\nHave you enabled sharing of study data with others?\tNo\nIf yes, describe or provide URLs to how it has been shared\tn/a\nIf no, explain why sharing hasn’t been enabled\tThe findings of this Phase I study have been shared with the Sponsor, Shionogi B.V., only. As these findings are confidential owing to commercial sensitivity, it is not appropriate to share the results of this study with other researchers at this time.\nHave you enabled sharing of tissue samples and associated data with others?\tNo\nIf yes, describe or provide a URL\tn/a\nIf no, explain why\tNot applicable as this study is a Phase I trial in healthy volunteers whose results are commercially sensitive.\n\n
Please find a link to the study here: ISRCTN - ISRCTN12615820: A mass balance study of a [14C]S-309309 oral capsule in healthy adult male participants https://www.isrctn.com/ISRCTN12615820?q=QSC207970&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10
REC name
London - Surrey Borders Research Ethics Committee
REC reference
23/LO/0015
Date of REC Opinion
22 Mar 2023
REC opinion
Further Information Favourable Opinion