Study to Investigate a New Drug in Healthy Subjects (SAD,FE,MAD,DDI)

• Research type

  Research Study

• Full title

  A Phase I, double-blind, randomized, placebo-controlled, ascending single and multiple oral dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ASP8232 in healthy subjects including an open label food effect part and a drug drug interaction part with itraconazole

• IRAS ID

  119646

• Contact name

  John Lambert

• Sponsor organisation

  Astellas Pharma Global Development - Europe

• Eudract number

  2012-004175-39

• ISRCTN Number

  to be registered

• Research summary

  ASP8232 is a new drug that is being investigated for the treatment of diabetic kidney disease. This study will be performed at the PAREXEL Early Phase Clinical Unit (London), Northwick Park Hospital, Watford Road, Harrow, HA1 3UJ. This will be a first-in-man clinical study in approximately 154 subjects and consisting of 4 parts: ?½ In Part 1 single doses will be administered to healthy male subjects, starting with a very small dose. ?½ In Part 2 it will be investigated in healthy male subjects whether food changes the drug concentrations of AP8232 in the body. ?½ In part 3, healthy subjects of both sexes, and of Caucasian and Japanese origin, will receive ASP8232 at multiple doses over several days. ?½ In part 4, the effect of another drug, itraconazole, on the blood levels of ASP8232 will be studied in healthy male subjects.

• REC name

  Wales REC 2

• REC reference

  12/WA/0354

• Date of REC Opinion

  7 Dec 2012

• REC opinion

  Favourable Opinion