TAK-438 - safety, blood levels & effects of repeated doses; ver 1

• Research type

  Research Study

• Full title

  A phase 1, randomized, double-blind, placebo-controlled, sequential-panel, multiple repeat dose study to evaluate the safety, tolerability, and pharmacokinetics of TAK-438 in healthy non-Japanese male subjects (HMR code 08-018)

• IRAS ID

  9042

• Contact name

  Steve Warrington

• Sponsor organisation

  Takeda Global Research & Development Centre (Europe) Ltd

• Eudract number

  2008-004975-22

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The study medicine is an experimental treatment for heartburn, which is usually caused by backflow of acidic stomach juices into the gullet (called 'acid reflux'). We hope that the study medicine will switch off acid production in the stomach, and work faster, better and for longer than existing medicines. We'll test daily doses of the study medicine, to find out any side effects, blood levels and effects on the acidity of stomach juices. 48 healthy men (4 groups of 12), aged 18-45 years, will take 7 daily doses. Each group of 12 volunteers will take a different dose. We'll start with a low dose, and increase the dose in the next 2 groups. The last group-s dose will be lower than the 3rd group-s dose. Some volunteers will take dummy medicine instead of the study medicine - neither the volunteers nor the study staff will know which volunteer is taking the dummy dose. Volunteers will take up to 5« weeks to finish the study. they'll make up to 3 outpatient visits, and stay on the ward for 10 nights. On 3 occasions, We'll pass a tube through each volunteeris nose, into the stomach, so we can monitor the acidity of stomach juices. We'll take many blood samples (two-thiris of a pint in total) to measure the amount and effects of the study medicine. Volunteers will not benefit from the study medicine, but they might benefit from ouriscreening tests, if we found an important problem. A pharmaceutical companynamed -Takeda- is funding the study.The study will take place at 1 centre in London. We'll recruit healthy volunteers by: advertising (newspaper, radio, and websites); by word of mouth; from volunteer databases; and via our websites.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  08/H0717/70

• Date of REC Opinion

  3 Nov 2008

• REC opinion

  Favourable Opinion