E6007-CP3 Phase I AME, Single dose in Healthy Adults
Research type
Research Study
Full title
A Phase I, Open-label, Study to Determine the Absorption, Metabolism, and Excretion of [14C]-E6007 After a Single Oral Administration in Healthy Male Subjects
IRAS ID
233234
Contact name
Ashley Brooks
Contact email
Sponsor organisation
EA Pharma Co., Ltd.
Eudract number
2017-004119-38
Duration of Study in the UK
0 years, 0 months, 25 days
Research summary
Inflammatory bowel disease, which includes ulcerative colitis and Crohn's disease, is an inflammatory, chronic disease of the gut with unknown cause and a relapsing-remitting course. Common clinical symptoms include diarrhoea, bloody stools and abdominal pain. If the disease worsens then other symptoms such as fever, loss of appetite and weight loss may occur. There are several treatments already on the market for inflammatory bowel disease, however some aren't so effective in severe disease and some aren't suitable for long-term use due to the risk of serious adverse drug reactions. Therefore the development of an oral medication that is highly effective and has a favourable risk/benefit profile will greatly contribute to the control inflammatory bowel disease and help to improve the patients' quality of life.
E6007 is a new anti-inflammatory agent currently in development and has been tested previously in humans as single oral doses up to 600mg and multiple oral doses up to 400mg/day.
The 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 E6007 and to characterize the metabolites (breakdown products) present in blood, urine and faeces in healthy male subjects following a single oral radiolabelled dose of 60mg of [14C]-E6007.
Subjects will be admitted to the Clinical Research Unit on Day-1 and be confined to the unit until at least Day 11 or as late as Day 15, based on the recovery of radioactivity from their urine and faeces. A single oral dose of [14C]-E6007 will be given on Day 1. Subjects will be discharged on Day 11 if all the following discharge criteria are met: >90% of radioactivity recovered and <1% of the total administered activity is recovered in combined excreta (urine and faeces) in 2 consecutive 24-hour periods.
If discharge criteria are not met by Day 11, subjects will remain in the unit up to a maximum of Day 15. If the discharge criteria have not been met by Day 15, subjects may be asked to attend up to 2 additional visits on a non-residential basis on Days 21 and 28 for collection of 24-hour excreta samples (urine and faeces).REC name
North East - York Research Ethics Committee
REC reference
17/NE/0281
Date of REC Opinion
11 Dec 2017
REC opinion
Favourable Opinion