Phase 1 study of ASP6973 First-in-man, Food Effect & Drug interaction

• Research type

  Research Study

• Full title

  A randomized, double blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics of single ascending oral doses of ASP6973 in healthy young male subjects, followed by an evaluation of food effect and an assessment of the interaction between ASP6973 and itraconazole, a CYP3A and P-gp inhibitor.

• IRAS ID

  98344

• Contact name

  Ashley Brooks

• Sponsor organisation

  Astellas Pharma Europe B.V.

• Eudract number

  2011-005120-17

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The study will be conducted in 3 parts. Part 1 will comprise 7 groups, each receiving a single dose. The first group will receive the lowest dose and the other groups will receive increasing doses. The aim of this part of the study is to evaluate the safety, tolerability and pharmacokinetics (i.e. how the body handles the drug) of the study drug. In addition, measurements will be taken to assess pharmacodynamics (i.e. the effect of the drug on the body). Part 2 will comprise one group, which will receive a single dose on 2 separate occasions, on one occasion after a period of fasting and on another occasion following a high fat breakfast to assess any effect of food on how the body handles the drug. Part 3 will comprise one group, which will be dosed once with study drug alone and on another occasion following multiple doses of itraconazole. This part of the study will evaluate if there is any interaction from itraconazole on how the body handles the study drug.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  12/SC/0092

• Date of REC Opinion

  21 Feb 2012

• REC opinion

  Favourable Opinion