AME of MT-8554 after a single oral dose in healthy male subjects
Research type
Research Study
Full title
An Open-label, Mass Balance Study to Investigate the Absorption, Metabolism and Excretion of [14C]-MT-8554 After a Single Oral Dose to Healthy Male Subjects
IRAS ID
233051
Contact name
Sunu Valasseri
Contact email
Sponsor organisation
Mitsubishi Tanabe Pharma Development America Inc. (MTDA)
Eudract number
2017-002830-21
Duration of Study in the UK
0 years, 1 months, 24 days
Research summary
MT-8554 is an investigational medicinal product currently being investigated for the treatment of neuropathic pain and other diseases. In various studies, MT-8554 has been well tolerated up to a dose of 900 mg as single dose and up to 400 mg as multiple doses for eight days.
Up to 6 healthy male participants will be participating in this Study.
The aims of this Study are to determine:• How the body gets rid of the Study Drug and how quickly
• How much of the Study Drug ends up in the urine and faeces
• How much of the Study Drug gets into the bloodstream
• The safety of the Study Drug and any side effects that might be associated with it
• The breakdown products of the Study Drug
This Study is for research purposes only and is not intended to treat any medical conditions.
Subjects will be screened within 28 days prior to dosing on Day 1. Each subject will reside at the CRU until at least Day 10. Subjects may be discharged from the clinic on day 10 if at least 90% of the administered radioactivity (based on the actual dose) has been recovered, or if 24 hour urine and faecal samples from 24 hour collections each have combined radioactivity less than 0.2% of the total administered radioactivity. Subjects may be asked to remain resident and continue excreta and blood collections up to Day 14 if the discharge criteria have not been met.
The effective radiation dose associated with this study is considered a minor risk for healthy subjects. The amount of radioactive material administered to the subjects is typical for this type of clinical trial and is necessary to be able to determine the levels of metabolites (drug breakdown products) in urine and faeces in order to achieve the objectives of the study.REC name
London - Brent Research Ethics Committee
REC reference
17/LO/1749
Date of REC Opinion
9 Nov 2017
REC opinion
Favourable Opinion