Blood levels of vedolizumab in Japanese & non-Japanese volunteers; v1

• Research type

  Research Study

• Full title

  A Phase 1, Open Label, Randomized, Parallel Group Study to Assess the Absolute Bioavailability and Pharmacokinetics of Vedolizumab in Healthy Subjects Following Single Subcutaneous Administration. (HMR code: 14-002)

• IRAS ID

  151281

• Sponsor organisation

  Takeda Development Centre Europe

• Eudract number

  2014-000927-26

• ISRCTN Number

  xx

• Clinicaltrials.gov Identifier

  xx

• Research summary

  The study medication being tested in this study is called vedolizumab. This drug is an experimental treatment for inflammatory bowel disease (IBD), in which the body’s immune system attacks its own digestive system. Vedolizumab is a monoclonal antibody, which is a protein made specifically to be used in humans. In this study, it is expected that by blocking a substance called integrin α4β7, vedolizumab can prevent the immune system from damaging the digestive system in participants with IBD.

  This study will test single doses of vedolizumab in healthy Japanese and non-Japanese volunteers, to find out its side effects, and to compare blood levels after it’s given by injection under the skin and infusion (slow injection) into a vein. This study will also test whether the body reacts to vedolizumab (ie does the body make antibodies against it?) and study how genes (pieces of DNA) affect the way the body responds to or handles vedolizumab.

  This study will enrol 24 Japanese volunteers, aged 20–60 years, and 24 non-Japanese volunteers, aged 18–60 years. Participants will be randomly assigned (by chance) to one of the four treatment groups. The participants will receive a single dose of either:
  * 54 mg,
  * 108 mg or
  * 160 mg vedolizumab as an injection under the skin; or
  * 300 mg vedolizumab as an infusion into a vein over 30 min.

  Participants will stay on the ward for 8 nights during 1 study session, make up to 9 outpatient visits, and have a telephone follow-up about 6 months after their dose. The overall time to participate in this study is up to 7 months.

  The study will take place at 1 centre in London.

  A pharmaceutical company (Takeda) is funding the study.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  14/LO/0466

• Date of REC Opinion

  8 Apr 2014

• REC opinion

  Favourable Opinion