TAK-937 - first doses in humans; version 1

• Research type

  Research Study

• Full title

  A Placebo Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of Escalating Doses of TAK-937 in Healthy Male Subjects. (HMR code 09-001)

• IRAS ID

  16985

• Sponsor organisation

  Takeda

• Eudract number

  2008-006711-20

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The study medicine is an experimental new medicine for treating stroke. A stroke happens when the blood supply to part of the brain is cut off. That harms brain cells. Depending on which part of the brain is damaged, a stroke can cause a wide range of disabilities, such as problems with speech, movement, eyesight, and memory. We hope that the study medicine will protect brain cells from being damaged by a shortage of blood. We'll test single doses of the study medicine, to find out its side effects, blood levels, and effects on mental state, balance, heart rate, and body temperature. We'll also study how genes (pieces of DNA) affect the way the body responds to, or handles, the medicine. At least 60 healthy men (6 groups of 10), aged 18-45 years, will be given the study medicine by slow injection, over about 1 h. It??s never been given to humans before, so We'll start with a small dose, and increase the dose as the study progresses. Some participants will get dummy medicine instead of the study medicine - neither they nor we will know which one they??re taking.Participants will take up to 5 weeks to finish the study. They??ll make 2 outpatient visits, and stay on the ward for 3 nights. We'll take blood samples often, to measure the amount of study medicine, and do tests of brain and heart function.Healthy volunteers can??t benefit from the study medicine, but they might benefit from our screening tests, if we found an important problem.A pharmaceutical company named Ó?Takeda? is funding the study.The study will be done at 1 centre in London. We'll recruit healthy participants by: advertising (newspaper, radio, and websites); by word of mouth; from volunteer databases; and via websites.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  09/H0717/15

• Date of REC Opinion

  5 Mar 2009

• REC opinion

  Favourable Opinion