The effect of Aleglitazar on PK of Digoxin

• Research type

  Research Study

• Full title

  An Open-label, Two-period Fixed-sequence Study to Investigate the Effect of Multiple Doses of Aleglitazar on a single Dose of Digoxin in Healthy Subjects

• IRAS ID

  111628

• Contact name

  Pui M Leung

• Sponsor organisation

  Roche Products Limited

• Eudract number

  2012-002269-36

• Research summary

  This is a research study with the following aims: ?½ To assess whether multiple doses of aleglitazar change the absorption, breakdown and elimination or removal from the body (called pharmacokinetics or PK) of a single dose of digoxin in healthy subjects ?½ To assess whether a single dose of digoxin affects the absorption, breakdown and elimination or removal from the body (called pharmacokinetics or PK) of aleglitazar and its metabolites, in healthy subjects ?½ To assess the safety and tolerability of aleglitazar when administered in combination with digoxin.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  12/NW/0551

• Date of REC Opinion

  16 Aug 2012

• REC opinion

  Favourable Opinion