MT-3995-E11 - Mass Balance Study
Research type
Research Study
Full title
An open-label, mass balance study to investigate the absorption, metabolism and excretion of [14C]-MT-3995 after a single oral dose to healthy male subjects
IRAS ID
204238
Contact name
Jim Bush
Contact email
Sponsor organisation
Mitsubishi Tanabe Pharma Corporation (MTPE)
Eudract number
2016-000151-26
Duration of Study in the UK
0 years, 4 months, 4 days
Research summary
MT-3995 is an investigational medicinal product being investigated for the treatment of diabetic kidney disease, high blood pressure and heart failure.
In various non-clinical studies, MT-3995 showed several potential benefits in terms of side effects and effectiveness compared to other similar drugs in the market.
MT-3995 was administered to healthy male subjects as single oral doses of 3.75 mg to 640 mg in Study MT-3995-E01. As of 29 February 2016, 14 studies have been initiated as part of the development program for MT-3995, including 507 enrolled subjects, of which an estimated 380 subjects have received MT-3995 in the seven completed Phase I and four completed Phase II studies. In the one ongoing Phase I and two ongoing Phase II studies, a total of 238 subjects have been randomised to receive MT-3995 or matching placebo. The results of these studies show that MT-3995 is generally well tolerated.The objective of this study is to find out what the body does to the drug and to determine the amount of drug recovered after a single oral dose. The study will also look at the ways through which the drug is removed from the body by measuring the breakdown of the drug and how much radioactivity can be found in whole blood, plasma, urine and faeces.
Subject will stay in the clinic from Day -1 (the day before dosing) to Day 11. Up to nine male subjects will receive a single 10 mg dose of [14C]-MT-3995 in the fasted state on Day 1. Each subject will return to the clinic for up to seven additional 24 hour Follow-up visits. Subjects will be discharged on the Day 85 visit. They may be discharged earlier if discharge criteria are met. The Follow-up Period may be extended to Day 99 if the subjects do not meet the discharge criteria on day 85.
The effective radiation dose associated with this study is considered only 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
North East - York Research Ethics Committee
REC reference
16/NE/0101
Date of REC Opinion
11 Jul 2016
REC opinion
Favourable Opinion