TAK-491 and chlorthalidone -- a new combined tablet; version 1

• Research type

  Research Study

• Full title

  A randomised, open-label, 2-period crossover study to determine the relative bioavailability of TAK-491CLD fixed-dose combination tablet compared to coadministration of individual TAK-491 and chlorthalidone tablets in healthy adult subjects (HMR code: 10-010)

• IRAS ID

  57504

• Contact name

  Steve Warrington

• Sponsor organisation

  TGRD

• Eudract number

  2010-020752-61

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  TAK-491 is an experimental new medicine for treating high blood pressure. It lowers blood pressure by blocking the action of angiotensin II, a hormone that increases blood pressure. Studies in patients show that TAK-491 lowers blood pressure more effectively when it is given with another medicine, called a diuretic (“water tablet”). Diuretics work by making people pass more salt in their urine.TAK-491CLD (the combined medicine) is an experimental new medicine that contains both TAK-491 and a diuretic “chlorthalidone“ in a single tablet. The combined medicine should be simpler and easier for patients to take, compared with taking the 2 medicines separately. We'll give 48 healthy men and women, aged 18??55 years, 2 single doses: 1 dose of the combined medicine and 1 dose of the 2 separate medicines. We aim to find out if blood levels of TAK-491 and chlorthalidone differ when they’re taken as a single tablet from when they’re taken as 2 separate tablets, and if they have any important side effects. Participants will take up to 8 weeks to finish the study. They'll make 1 outpatient visit, and have 2 study sessions. They'll stay on the ward for 6 days and nights in each session. We'll take blood samples to measure the amount of the TAK-491 and chlorthalidone, and do safety tests to check participants have come to no harm. The study also includes a blood sample for pharmacogenetic research, which looks into how genes (pieces of DNA) affect the way the body responds to or handles medicines. A pharmaceutical company (Takeda Global Research and Development Centre (Europe) Limited) is funding the study. The study will take place at 1 location in London. We'll recruit healthy participants by advertising (newspaper, radio, and websites), by word of mouth, from volunteer databases, and via our websites.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  10/IEC04/15

• Date of REC Opinion

  14 Jul 2010

• REC opinion

  Further Information Favourable Opinion