Evaluation of safety,tolerability & PK of DSP-2230 in healthy subjects

• Research type

  Research Study

• Full title

  A Phase 1, 3-part study, in healthy subjects to assess the safety, tolerability and pharmacokinetics (PK)of single and multiple doses of DSP-2230, and the effect of the administration of DSP-2230 in the fed and fasted states on the PK of DSP-2230.

• IRAS ID

  103329

• Contact name

  Peter Dewland

• Sponsor organisation

  Dainnippon Sumitomo Pharma Europe Ltd.

• Eudract number

  2012-000316-29

• Research summary

  This study is an evaluation of the safety, tolerability and pharmacokinetics of DSP-2230 in healthy subjects. The investigational study drug DSP-2230 is being developed by the sponsor, Dainippon Sumitomo Pharma Europe Ltd. as an intended treatment for a very painful condition caused by a disease in the nerves called peripheral neuropathy. This study will be the first time DSP-2230 is administered to humans. The aim of the study is to assess the effects of a suspension formulation of DSP-2230 in 3 parts. Part 1 will assess the safety, tolerability and blood/urine levels of ascending single doses of DSP-2230. In Part 2, blood levels of DSP-2230 will be assessed when administered with food and also without food. In Part 3, the safety, tolerability and blood/urine levels of DSP-2230 will be assessed following dosing for 14 days. PART 1: Up to 8 groups of 9 subjects may be enrolled. In each group 6 subjects will receive a single oral dose of DSP-2230 and 3 will receive placebo (dummy drug). The order in which volunteers will be allocated to treatment is random. The dose will be increased in each cohort. PART 2: A total of 12 healthy subjects will receive a single oral dose of DSP-2230 in each of the 2 treatment periods. The order of the treatment periods for each subject will be determined by chance. Apart from whether subjects will receive a high fat breakfast, both treatment periods will be the same. PART 3: Up to 6 groups of 12 healthy volunteers may be enrolled. In each group 9 volunteers will receive multiple oral doses of DSP-2230 and 3 will receive placebo. Treatment allocation is random. The dose will be increase in each cohort. Subjects are expected to attend a screening visit, treatment period(s) and follow up visit on each part of the study.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  12/NW/0286

• Date of REC Opinion

  11 May 2012

• REC opinion

  Further Information Favourable Opinion