Single & multiple dose, food effect, gender and age study
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled study to investigate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of MT-8554 in healthy subjects, including the effect of food, gender and age on the pharmacokinetics of a single dose of MT-8554 in healthy subjects
IRAS ID
174129
Contact name
Jim Bush
Contact email
Sponsor organisation
Mitsubishi Tanabe Pharma Europe Ltd (MTPE)
Eudract number
2015-000214-22
Duration of Study in the UK
0 years, 4 months, 0 days
Research summary
This Study is the first time that the Study Drug is being given to humans. 108 subjects are planned to participate in this Study, although up to 136 may be included.
This study will be conducted in five parts.
Part A of the study has been designed to look at how safe and well-tolerated a single dose of the study drug is in, healthy male Caucasian subjects. This part of the study will also measure the amount of study drug in the blood. One group of subjects from Part A will also be selected to participate in Part B.Part B of the study has been designed to look at whether taking the capsules with food affects the amount of study drug that gets into the blood in healthy male Caucasian subjects. Subjects will be given the study drug following a cooked, high-fat breakfast.
Part C of the study has been designed to look at how safe and well tolerated repeated doses (for up to 10 consecutive days) of the study drug are in healthy male Caucasian subjects. This part of the study will also measure the study drug in the blood, how long it takes the body to remove it after repeat doses and what effect the drug has on the body.
Parts D and E of the study have been designed to see how safe and well tolerated a single dose of the study drug is when given to female Caucasian or elderly male Caucasian subjects, respectively. These results from female and elderly male subjects will be compared to healthy male Caucasian subjects.
REC name
London - Brent Research Ethics Committee
REC reference
15/LO/0395
Date of REC Opinion
21 Apr 2015
REC opinion
Further Information Favourable Opinion