SMP-028/Midazolam Drug:Drug Interaction Study Version 1

• Research type

  Research Study

• Full title

  AN EXPLORATORY RANDOMISED, OPEN LABEL, TWO-PERIOD, CROSSOVER STUDY IN HEALTHY SUBJECTS TO EVALUATE THE EFFECT OF SMP-028 ON THE PHARMACOKINETICS OF MIDAZOLAM

• IRAS ID

  47296

• Contact name

  Prashil Koovejee

• Sponsor organisation

  Dainippon Sumitomo Pharma Europe Ltd

• Eudract number

  2009-018238-13

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Research involves a new drug being developed for the treatment of asthma. This new drug can affect the activity of enzymes (naturally occurring compounds that speed up chemical reactions) in the liver. This study will investigate if this new drug affects the levels of another drug in the blood (probe agent) due to this effect on liver enzymes. This will provide information to help decide which medications can be taken safely with the new drug.study requires healthy male and female volunteers aged between 18 and 55. Females must be of non-childbearing potential (sterilised or post-menopausal). Study will be conducted at a specialist clinical trials unit. Participation will last approximately 31 days and will consist of 4 visits to the unit with a total of 10 overnight stays. Volunteers will have blood samples taken and health checks made before and after taking the study drug and the probe agent.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/IEC01/5

• Date of REC Opinion

  15 Mar 2010

• REC opinion

  Further Information Favourable Opinion