TAK-653 - first doses in humans; ver1
Research type
Research Study
Full title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Escalating Single and Multiple Doses of TAK-653 in Healthy Subjects. (HMR code: 15-013)
IRAS ID
184694
Contact email
Sponsor organisation
Takeda Development Centre Europe Ltd
Eudract number
2015-002268-17
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
TAK-653 (the study medicine) is an experimental treatment for a type of depression called major depressive disorder (MDD). Existing medicines don’t work almost one third of patients with MDD. We hope TAK-653 will work in a different way. We hope that it will increase levels or activities of substances in the brain that are linked with mood, attention and memory, and improve symptoms in patients with MDD.
The study medicine has never been given to humans before, so we’ll start with a small dose, and increase the dose as the study progresses. We aim to find out its side effects and blood levels, and its effects on the electrical activity in the brain. We’ll also test whether food affects blood levels of the study medicine after single doses.
We’ll test the study medicine in 72 healthy men and women, aged 18–55 years, in 2 study parts:
* Part 1: up to 40 participants, in 5 groups of 8, will each have a single dose of study medicine after fasting. They’ll take up to 7 weeks to finish the study, stay on the ward for 5 nights in a row, and make 1 outpatient visit. One group of participants will have another single dose after a high-fat breakfast; they’ll take up to 10 weeks to finish the study, and stay on the ward for 10 nights in total.
* Part 2: up to 32 participants, in 4 groups of 8, will have single and repeated doses of study medicine. Participants will take up to 8 weeks to finish the study, stay on the ward for 19 nights in a row, and make 1 outpatient visit.
A pharmaceutical company (Takeda Development Centre Europe Ltd) is funding the study.
The study will take place at 1 centre in London.
REC name
Scotland A: Adults with Incapacity only
REC reference
15/SS/0117
Date of REC Opinion
10 Aug 2015
REC opinion
Further Information Favourable Opinion