A study to assess interactions between furosemide and ipragliflozin

• Research type

  Research Study

• Full title

  A clinical pharmacological study to assess pharmacodynamic and pharmacokinetic interactions between furosemide and ipragliflozin in healthy subjects.

• IRAS ID

  81698

• Contact name

  Ashley Brooks

• Sponsor organisation

  Astellas Pharma Europe B.V. (APEB)

• Eudract number

  2010-024071-98

• Research summary

  ASP1941 is being developed as an oral-tablet formulation for mono-therapy and/orCombination therapy for treatment of type 2 diabetes mellitus (T2DM).This will be a study to assess interactions between furosemide and the study drug in healthy subjects.This will be a three-period, multiple dose study. Subjects will receive the three following dose regimens in randomized order:A. Study Drug ASP1941: 150 mg once daily for 5 daysB. Furosemide: 40 mg once daily for 5 days C. Study drug ASP1941 furosemide: 150 mg Study Drug ASP1941 once daily for 5 days 40 mg furosemide once daily for 7 daysIn total 24 healthy male and female subjects will be randomized. Subjects will be admitted to the clinical unit for 3 periods of 13 days (12 nights) each. Admission is on Day -5. Starting from admission to day 5 (10 days) subjects will be given meals and drinks in which electrolytes are controlled to certain pre determined levels. There is a 5 or 7 day dosing period from Day 1 onwards. There will be a wash-out period of at least 7 days between periods. Subjects will have another visit to the unit around 7 to 14 days after the completion of the third treatment period.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/IE/0102

• Date of REC Opinion

  27 Jun 2011

• REC opinion

  Favourable Opinion