Study to Assess the Pharmacokinetic Interaction of Two Medications

• Research type

  Research Study

• Full title

  An open-label, single-dose, two-period, single sequence study to assess the pharmacokinetic interaction of indacaterol (300 µg via oral inhalation) with ritonavir (300 mg b.i.d.) in healthy adult subjects.

• IRAS ID

  26208

• Contact name

  B J Colgan

• Eudract number

  2009-012638-65

• Research summary

  This study will involve the use of a new medication that's being developed by the Sponsor as an inhaled medication for the treatment of chronic obstructive pulmonary disease (COPD). COPD refers to two diseases of the lungs that commonly occur together (chronic bronchitis and emphysema) in which the airways become narrowed, leading to shortness of breath. COPD usually gets progressively worse over time.The new medication works by relaxing and opening the airways improving the passage of air into the lungs (bronchodilation) making it easier to breathe. Information available from studies conducted to date suggests that new medication is an effective, once-daily bronchodilator that begins to work in the body quickly and continues to work over a 24-hour period. As there are currently no marketed once-daily treatments for COPD, such a medication would be a significant treatment advance.The purpose of this study is to find out if the amount of and rate at which the new medication gets into and is removed from the body's affected when given with ritonavir. The safety of the new medication when given with ritonavir will also be assessed.Ritonavir is a marketed medication that stops certain chemicals in the body that breakdown medication from working. This leads to higher blood levels of the medications allowing their dose and frequency to be lowered. Ritonavir is often used in combination with antiretroviral medications (HIV treatments). It is usually given as a 300 mg dose twice-a-day (with 12 hours between doses). During this study, volunteers will receive a single inhaled dose of the new medication on two separate occasions: once alone; and then in combination with multiple oral ritonavir doses. All volunteers will receive the same treatment in each of two assessment periods. There will be an interval of at least 15 days (maximum of 21 days) between the two doses of the new medication. A total of approximately 18 male and/or female volunteers (aged between 18 and 45) will take part in this study at one centre in the UK. The maximum duration of the study from screening until the Study Completion visit (based on a maximum washout interval of 21 days and Study Completion visit performed 9 days after the last visit in Period 2) could be up to 52 days for each volunteer.

• REC name

  Scotland A REC

• REC reference

  09/IEC02/13

• Date of REC Opinion

  2 Jul 2009

• REC opinion

  Favourable Opinion