Effect of MT-8554 on QT/QTc interval in healthy adults
Research type
Research Study
Full title
A phase I, randomised, double-blind, placebo-controlled, parallel-group study to evaluate the effect of MT-8554 at two dose levels, 10 mg and 100 mg, on the QT/QTc interval in healthy adult subjects
IRAS ID
237687
Contact name
Jim Bush
Contact email
Sponsor organisation
Mitsubishi Tanabe Pharma Europe, Inc.
Eudract number
2017-004138-27
Clinicaltrials.gov Identifier
18/LO/0073, REC
Duration of Study in the UK
0 years, 3 months, 10 days
Research summary
Mitsubishi MT-8554 is a drug developed by Mitsubishi Tanabe Pharma corporation, it is an agonist of a receptor called transient receptor potential melastatin 8 (TRPM8). This receptor is expressed on neurons that play an essential role in the sensation of environmental cold. The purpose of the drug is to treat vasomotor symptoms (hot flashes, flushing and night sweats) and neuropathic pain. The study drug has been well tolerated in recently completed phase I clinical trials.
The purpose of this trial is to assess the effects of MT-8554 on the rhythm and rate of the heart. This will be observed by comparing if there are any changes before and after the study drug is given to the subjects. Subjects will be confined to the unit for 10 days with a follow up visit 14 days from leaving the unit. Subjects will be dosed once per day for 7 days.
There will be 48 subjects enrolled into the study in two groups. Each group will consist of 24 subjects.
Group one will be given 10mg of the study drug daily before breakfast, and assessed at different time points through the day the intensive ECG monitoring on days 1 and 7-9. Subjects will receive either the study drug or a placebo, 18 of the subjects will receive the study drug and 6 will receive the placebo.
Group two will be given 100mg of the study drug before breakfast and be monitored in the same way as Group one; this group will also have 6 subjects on a placebo and 18 on the study drug.REC name
London - Brent Research Ethics Committee
REC reference
18/LO/0073
Date of REC Opinion
31 Jan 2018
REC opinion
Favourable Opinion