A phase 1 study evaluating [14C]-Lenabasum in healthy males
Research type
Research Study
Full title
A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Lenabasum Following a Single Oral Dose in Healthy Male Subjects
IRAS ID
245388
Contact name
Ashley Brooks
Contact email
Sponsor organisation
Corbus International Limited
Eudract number
2018-001576-38
Clinicaltrials.gov Identifier
18/LO/0572, REC
Duration of Study in the UK
0 years, 1 months, 2 days
Research summary
The Study Drug (Lenabasum) is an investigational drug which is being developed by the sponsor, with an aim to help people with conditions such as systemic sclerosis, cystic fibrosis, dermatomyositis and systemic lupus erythematosus. \nThese conditions are known as ‘autoimmune diseases’. This means that the immune system attacks healthy tissues and causes damage, which can result in severe symptoms such as weakness, pain, fatigue, skin problems, and can result in major organ involvement. There are currently limited treatments available and the current treatments for these conditions have side effects, including an increase in the number of infections. It is hoped that lenabasum will have fewer side effects (cause fewer infections) and be more effective. \nThe purpose of this trial is to determine the absorption (how the drug gets into the body), metabolism (how the drug is broken down) and excretion (removal of drug by the body) of lenabasum and to characterize the metabolites (breakdown products) present in blood, urine and faeces in healthy male subjects following a single oral radiolabelled dose of 20mg of [14C]-lenabasum.\nSubjects will be admitted to the Clinical Research Unit on Day-1 and be confined until at least Day 6 or as late as Day 8, based on the recovery of radioactivity from their urine and faeces. A single oral dose of [14C]-lenabasum will be given on Day 1. Subjects will be discharged if all the following criteria are met: radioactivity levels in the blood are below quantifiable levels, >90% of radioactivity recovered and <1% of the total administered radioactivity is recovered in combined excreta (urine and faeces) in 2 consecutive 24-hour periods. If discharge criteria are not met by Day 6, subjects will remain in the unit up to a maximum of Day 8. If the discharge criteria have not been met by Day 8, subjects may be asked to attend up to 2 additional visits on a non-residential basis on Days 9 and 10 for collection of 24-hour excreta samples (urine and faeces). \n
REC name
London - Brent Research Ethics Committee
REC reference
18/LO/0572
Date of REC Opinion
2 Jul 2018
REC opinion
Further Information Favourable Opinion