Safety, Tolerability, PK and PD of MT-7117 in Healthy Subjects
Research type
Research Study
Full title
A Randomised, Double-blind, Placebo-controlled Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of MT-7117 in Healthy Subjects
IRAS ID
208020
Contact name
Muna Albayaty
Contact email
Sponsor organisation
Mitsubishi Tanabe Pharma Corporation (MTPC)
Eudract number
2016-001326-33
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 8 months, 1 days
Research summary
This is a phase 1, randomised, double-blind, placebo controlled clinical study being conducted to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MT-7117. The study is comprised of 8 study parts all of which will enrol healthy volunteers of different ages, races, genders and skin types. \n\nThis will be the first time MT-7117 is given to human participants and is a First in Human (FiH) clinical trial. MT-7117 is being developed by Mitsubishi Tanabe Pharma Corporation (MTPC) for the treatment of Erythropoietic protoporphyria (EPP). EPP is an inherited genetic disorder (i.e. it is caused by a fault in the person’s DNA) which causes sensitivity to the sun which results in stinging, itching, burning and severe pain. It can also cause redness and swelling of the skin and red / purple spots called petechiae. Liver effects are also seen in some patients.\n\nThe main purpose of the study is to see how safe the drug is after single and multiple doses, and how well the body tolerates the drug after single and multiple doses. The study will also investigate how the drug is absorbed (taken up into the body), metabolised (chemically broken down), distributed through the body, and excreted (removed from the body). The study will also look the effect of the following on the study drug:\n- Gender\n- Race\n- Food\n- Age\n- Differences between drug taken as tablet or oral solution\n- Molecules and genes in the skin as well as pigmentation of the skin
REC name
London - Brent Research Ethics Committee
REC reference
16/LO/0813
Date of REC Opinion
30 Jun 2016
REC opinion
Further Information Favourable Opinion