The effect of Rifampicin on PK of aleglitazar and its metabolites

• Research type

  Research Study

• Full title

  An Open-label, Fixed-sequence, Three-period, Single Group Study to Investigate the Effects of Rifampicin as an OATP1B1 Inhibitor and a CYP2C8 Inducer on the Pharmacokinetics of Aleglitazar in Healthy Subjects

• IRAS ID

  108056

• Contact name

  Pui M Leung

• Sponsor organisation

  F. Hoffmann-La Roche Ltd

• Eudract number

  2012-002274-31

• ISRCTN Number

  1

• Research summary

  This is a research study with the following aims: ?½ To assess whether a single dose of rifampicin changes 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 whether multiple doses of rifampicin change 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 rifampicin. Aleglitazar is a new drug that is being developed by the Sponsor for the purpose of treating patients with type 2 diabetes following an acute coronary syndrome attack. Aleglitazar has a beneficial effect on cholesterol (a fatty substance in the body which can cause blockage of arteries), and helps insulin (a vital hormone in the body that lowers blood sugar) work more effectively. Aleglitazar has already been administered in healthy subjects and in patients with type 2 diabetes mellitus, without any safety concerns. Rifampicin is a well-established marketed medication used in the treatment of tuberculosis for many years. Rifampicin is also used commonly in studying the effect of metabolism (handling of drug in the body) of many new drugs in studies in humans. The dose of rifampicin used in this study will be the maximum recommended dose (600 mg) in adults. A total of 24 healthy male or female volunteers 18-55 years of age inclusive will be enrolled in the study. Volunteers will attend three treatment periods where they will receive: TP 1 a single dose of aleglitazar TP 2 a single dose of rifampicin followed by a single dose of aleglitazar TP 3 seven days of rifampicin dosing followed by a single dose of aleglitazar on Day 8. Volunteers are expected to complete 11 visits in total, three of which will involve five-night stays and one will involve one-night stay at the Clinical Unit.

• REC name

  Wales REC 2

• REC reference

  12/WA/0213

• Date of REC Opinion

  24 Jul 2012

• REC opinion

  Further Information Favourable Opinion