Safety and blood levels of DS-1093a; version 1

• Research type

  Research Study

• Full title

  A double-blind, randomised, placebo-controlled, multiple ascending-dose study to assess the pharmacokinetics, pharmacodynamics, safety and tolerability of DS-1093a in healthy male subjects. HMR code 14-005

• IRAS ID

  153443

• Contact name

  Adeep Puri

• Contact email

  rec@hmrlondon.com

• Sponsor organisation

  Daiichi Sankyo Development Ltd

• Eudract number

  2014-000552-28

• ISRCTN Number

  xx

• Clinicaltrials.gov Identifier

  xx

• Research summary

  DS-1093a is an experimental new medicine for treating anaemia. Anaemia is a condition in which there is a low red blood cell count or lack of haemoglobin (the substance in red blood cells that carries oxygen from the lungs to the rest of the body) in patients with chronic kidney disease. Anaemia causes paleness, shortness of breath and lack of energy.

  We hope that DS-1093a will work by increasing the levels of a substance called erythropoietin, which is made by the kidney and increases production of red blood cells. Medicines containing erythropoietin are used to treat anaemia caused by chronic kidney disease, but they must be given by injection. DS-1093a can be taken by mouth.

  We’re doing this study to find out the side effects and blood levels of repeated doses of DS 1093a, and its effects on substances linked to red blood cell production. We’ll also test how genes (pieces of DNA) affect the way the body handles DS-1093a.

  We’ll give up to 32 healthy men (in 4 groups of 8), aged 18–45 years, once-daily doses of DS-1093a for 14 days. We’ll start with a low dose in Group 1, and plan to increase the dose as the study progresses. We’ll study up to 4 dose levels: Groups 3 and 4 are optional. Some participants will take dummy medicine instead of DS-1093a. Neither the participants nor we will know which treatment they’re taking.

  Participants will take up to 17 weeks to finish the study. They’ll make 6 outpatient visits and stay on the ward for 21 nights in a row.

  A pharmaceutical company (Daiichi Sankyo Development Ltd.) is funding the study.

  The study will take place in one centre in London. We’ll recruit participants by: advertising (newspaper, radio, and websites); word of mouth; volunteer databases; and our websites.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  14/LO/0404

• Date of REC Opinion

  7 May 2014

• REC opinion

  Favourable Opinion