Single Oral Dose of MT-7117 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-7117 After a Single Oral Dose to Healthy Male Subjects
IRAS ID
238878
Contact name
Jim Bush
Contact email
Sponsor organisation
Mitsubishi Tanabe Pharma Development America
Eudract number
2017-004549-25
Clinicaltrials.gov Identifier
REC Reference , 18/NE/0002
Duration of Study in the UK
0 years, 1 months, 18 days
Research summary
This is a single centre, open-label (where both the subjects and physicians are aware they are taking the active form of a medication) Mass-balance (Checking the absorption, metabolism and excretion in urine and faeces) in healthy Caucasian subjects utilising a single dose of radiolabelled MT-7117.
MT-7117 is being investigated to prevent skin reactions in a disease called erythropoietic protoporphyria (EPP). It is inherited disorder of haem synthesis which can cause protoporphyrin (a by-product of haemoglobin synthesis) to build up in the blood, skin and tissues of the body. Upon exposure to sun the build-up of protoporphyrin causes severe skin reactions to occur.
3% of those with EPP can develop liver complications and may require a transplant. EPP is a lifelong disease and can cause severe effects on the quality of life of its sufferers.
This study will be investigating the absorption, metabolism and excretion of a 100 mg single dose of radio labelled MT-7117 in a group of 6 healthy Caucasian subjects.
Subjects will be confined to the unit from day -1 to day 8 and may stay up to day 14 dependant on if >90% of the drug is excreted by day 8.
Subjects will return to the unit for a follow up visit on day 15 or at early termination.REC name
North East - York Research Ethics Committee
REC reference
18/NE/0002
Date of REC Opinion
14 Feb 2018
REC opinion
Favourable Opinion