Study to assess effects of Aleglitazar on PK and PD of Microgynon

• Research type

  Research Study

• Full title

  A single centre, randomised, double-blind, placebo-controlled, crossover, multiple-dose study in healthy females to assess the effect of Aleglitazar on the pharmacokinetics and pharmacodynamics of Microgynon. MICROGYNON.

• IRAS ID

  103859

• Contact name

  Peter Dewland

• Sponsor organisation

  F. Hoffmann-La Roche Ltd

• Eudract number

  2011-004012-37

• Research summary

  This is a research study with the following aims: ?½ To assess the effect of aleglitazar on the effect of the body on a drug (pharmacokinetics) of microgynon, a combined oral contraceptive pill, in healthy female subjects ?½ To assess the effect of aleglitazar on the effect of the drug on the body (pharmacodynamics ) of microgynon in healthy female subjects ?½ To assess the safety and tolerability of aleglitazar when administered with microgynon. 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. It is likely that women on aleglitezar will be taking oral contraceptives. Therefore, it is important to know if aleglitazar can be administered with the combined oral contraceptive pill without any untoward consequences. We are assessing how aleglitazar affects the blood levels of the combined oral contraceptive - Microgynon. The dose of Microgynon will be same as is usually given, namely one tablet a day. A total of 18 healthy pre-menopausal female volunteers 18-45 years of age inclusive will be enrolled in the study. Volunteers will attend two treatment periods where they will be dosed daily with Microgynon for 21 days (Day 1 - Day 21) and 9 volunteers will receive aleglitazar for 15 days (Day 1 - Day 15) in one treatment period, while remaining volunteers receive a placebo (dummy drug) at that time. In second treatment period volunteers will receive the opposite drug. The order in which volunteers will recive the study drug or placebo will be assigned at random. Volunteers are expected to complete 9 visits in total, two of which will involve three-night stays at the Clinical Unit.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  12/NW/0285

• Date of REC Opinion

  18 May 2012

• REC opinion

  Further Information Favourable Opinion