A study to compare different formulations of RDC5 in Healthy Volunteer

• Research type

  Research Study

• Full title

  A Phase I, Open-label, Randomised, 3-way Crossover Study to Characterise and Compare the Pharmacokinetics, Safety and Tolerability of RDC5 Given as a Single Dose to Healthy Volunteers

• IRAS ID

  139943

• Contact name

  Girish Sharma

• Contact email

  girish.sharma@simbec.co.uk

• Sponsor organisation

  Chronos Therapeutics

• Eudract number

  2013-003335-29

• ISRCTN Number

  to be registered

• Research summary

  This is an open-label, randomised, single dose, 3-way crossover study to characterise and compare the PK, safety and tolerability of RDC5 in 15 healthy male volunteers. Eligible subjects will undergo 3 Treatment Periods, each separated by a washout period at least 14 days. Subjects will receive a single dose of RDC5 during each of the three Treatment Periods in line with their randomized treatment sequence. A total of 4 dose levels will be evaluated within the study, though each subject will only receive 3 doses. A Data Review Team (DRT) will review the pharmacokinetic (PK) data from Treatment Periods 1 and 2 and select the doses to be evaluated in Treatment Periods 2 and 3. Subjects will return for a follow visit 21 days after the last dose of RDC5

• REC name

  Wales REC 1

• REC reference

  13/WA/0277

• Date of REC Opinion

  4 Oct 2013

• REC opinion

  Favourable Opinion