Can TAK-137 stop brain impairments caused by ketamine? ver 1
Research type
Research Study
Full title
A randomized, sponsor-unblinded, placebo-controlled, 4-period, crossover study to evaluate the effects of single oral administrations of TAK-137 on reversing ketamine-induced cognitive deficits as well as brain activity changes captured by functional magnetic resonance imaging and electroencephalogram in healthy male adults (HMR code: 14-007)
IRAS ID
158773
Contact name
Adeep Puri
Contact email
Eudract number
2014-000787-18
Research summary
TAK-137 (the study medicine) is being developed for the potential treatment of long term illnesses that affect the way you think, feel or behave, such as schizophrenia. We’re not sure what causes schizophrenia, but it’s been linked to chemical imbalances in the brain. We hope that TAK-137 will activate areas in the brain to help correct that imbalance.
In this study, up to 24 healthy men, aged 18–45 years, will have 4 study sessions. In each session, they’ll take:
* a single oral dose of 0.5 mg, 5 mg or 20 mg TAK-137, or placebo; and
* a low dose of ketamine, by slow infusion in a vein, to mimic symptoms of schizophrenia.
Ketamine is an approved medicine, widely used by doctors as an anaesthetic (medicine used to put patients to sleep).We’ll check the effect of TAK-137 on the brain and whether it reduces the effects of ketamine, using:
* functional MRI scans, which use a powerful magnet to take pictures of areas of activity in the brain;
* EEGs, to measure electrical activity in the brain; and
* questionnaires and computer tests.
We’ll also check whether TAK-137 has any side effects, how its blood levels are linked to effects on the brain, and how genes (pieces of DNA) and gene products (RNA) affect the way the body responds to or handles medicines.Participants will take up to 15 weeks to finish the study. They’ll make 2 outpatient visits, and stay on the ward for 2 nights in each session (8 nights in total).
A pharmaceutical company (Takeda Development Centre Europe Ltd) is funding the study.
The study will take place at HMR and King’s College Hospital (KCH) in London. Dosing, the fMRI scans, EEGs, questionnaires and computer tests will be done at KCH.
REC name
Scotland A REC
REC reference
14/SS/1024
Date of REC Opinion
10 Sep 2014
REC opinion
Further Information Favourable Opinion