* Study of PK, Mass Balance and Metabolite Profile of [14C]-MBS2320 (IST-04 / QSC205085)
Research type
Research Study
Full title
An Open Label, Single-Dose, Single-Period Study Designed to Assess the Pharmacokinetics and Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-MBS2320 in Healthy Male Subjects
IRAS ID
1005686
Contact name
Kerry Hylands
Contact email
Sponsor organisation
Modern Biosciences Ltd.
Eudract number
2022-001537-36
ISRCTN Number
ISRCTN16794199
Research summary
The Sponsor is developing the test medicine, MBS2320, for the potential treatment of rheumatoid arthritis (RA) and idiopathic pulmonary fibrosis (IPF). Rheumatoid arthritis is a long-term condition that causes pain, swelling and stiffness in the joints. Idiopathic pulmonary fibrosis is a condition in which the lungs become scarred and breathing becomes increasingly difficult.
This single period healthy volunteer study will try to identify how the test medicine is taken up, broken down and removed by the body when given in liquid form (oral solution). To help us investigate how this happens, the test medicine will be radiolabelled. ‘Radiolabelled’ means that the test medicine has a radioactive component (carbon-14) which helps us to track where the test medicine is in the body and how it is removed.
This study will take place at one non-NHS site, enrolling up to 6 male volunteers aged between 30 to 65.
On Day 1, volunteers will receive a a single administration of [Cyclohexane-U-14C]-MBS2320, 15 mg (NMT 4.5 MBq) as an oral solution, in the fasted state.
Volunteers will remain in the clinical unit Day 8, however if the relevant radioactivity criteria have not been met, volunteers may be required to remain at the clinic until Day 10. If relevant criteria have not been met at this point, home collections of urine and/or faeces may be required.
Volunteer’s blood, urine and faeces will be taken throughout the study for analysis of the test medicine and for their safety.
Volunteers are expected to be involved in this study for 6 weeks from screening to discharge.REC name
London - West London & GTAC Research Ethics Committee
REC reference
22/FT/0085
Date of REC Opinion
18 Aug 2022
REC opinion
Further Information Favourable Opinion