FF & GW642444M: interactions with ketoconazole; version 1

• Research type

  Research Study

• Full title

  A double-blind, randomized, placebo-controlled, repeat dose, 2-way crossover drug interaction study to investigate the pharmacokinetic and pharmacodynamic effects following administration of fluticasone furoate/GW642444M inhalation powder with ketoconazole

• IRAS ID

  55491

• Contact name

  Steve Warrington

• Sponsor organisation

  GlaxoSmithKline

• Eudract number

  2010-019976-56

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Fluticasone furoate (FF) and GW642444M, the study medicines, are experimental inhaled treatments that will be used in combination for asthma and chronic obstructive pulmonary disease (COPD). People with asthma and COPD suffer from breathlessness because the small tubes (bronchioles) that carry air in and out of the lungs become inflamed and narrow. FF reduces the inflammation and GW642444M relaxes the bronchioles, making it easier to breathe. People with asthma and COPD might take other medicines, such as ketoconazole for fungus infections. So, we aim to find out if ketoconazole affects blood levels of FF and GW642444M, and if so, whether they then cause more side effects. We'll recruit 18 healthy men and women, aged 18??64 years. The study comprises 2 treatment periods, separated by an interval of 7 days. Participants will take ketoconazole or placebo (dummy medicine) as capsules once daily for 11 days in each treatment period: some participants will take placebo in the first treatment period and ketoconazole in the second; and the remaining participants will take ketoconazole first and placebo second. From Day 5 in each treatment period, the participants will inhale a combination of FF and GW642444M, once daily for 7 days. They??ll stay in the research unit for a total of 10 nights and will complete the study in 11 weeks.This study will take place at a specialist research centre in London. We'll recruit participants by advertising (newspaper, radio, and websites), word of mouth, from volunteer databases, and via our websites.GlaxoSmithKline is paying for the study.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  10/IEC04/12

• Date of REC Opinion

  21 Jun 2010

• REC opinion

  Favourable Opinion