DS-1093a – first doses in humans; version 1

• Research type

  Research Study

• Full title

  A double-blind, randomised, placebo-controlled, single ascending-dose study to assess safety, tolerability, pharmacokinetics and pharmacodynamics of DS-1093A in healthy male subjects. HMR code 13-005

• IRAS ID

  135883

• Contact name

  Malcolm Boyce

• Contact email

  vparker@hmrlondon.com

• Sponsor organisation

  Daiichi Sankyo Development

• Eudract number

  2013-002256-32

• ISRCTN Number

  Not provided

• Clinicaltrials.gov Identifier

  Not provided

• Research summary

  DS-1093a is an experimental new medicine for treating anaemia (low red blood cell count) or deficiency of haemoglobin (the substance in red blood cells that carries oxygen from the lungs to the tissues) in patients with chronic kidney disease. Anaemia causes pallor, 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 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. DS-1093a has never been given to humans before, so we’ll start with a low dose, and increase it as the study progresses.

  We’re doing the study in up to 64 healthy men, aged 18–45 years.

  Participants will take a single dose of DS-1093a. 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 5 weeks to finish the study. They’ll make 6 outpatient visits and stay on the ward for 5 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

  13/LO/1071

• Date of REC Opinion

  22 Aug 2013

• REC opinion

  Further Information Favourable Opinion