SMP-028/Ketoconazole 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 KETOCONAZOLE ON THE PHARMACOKINETICS OF SMP-028

• IRAS ID

  46055

• Contact name

  PRASHIL KOOVEJEE

• Sponsor organisation

  Dainippon Sumitomo Pharma Europe Ltd

• Eudract number

  2009-018237-37

• Research summary

  THE STUDY DRUG IS A NEW DRUG BEING DEVELOPED FOR THE TREATMENT OF ASTHMA. WHEN THIS DRUG IS TAKEN IT IS METABOLISED (BROKEN DOWN) BY ENZYMES (NATURALLY OCCURRING COMPOUNDS THAT SPEED UP CHEMICAL REACTIONS) IN THE LIVER. THIS STUDY WILL INVESTIGATE IF ANOTHER DRUG (PROBE AGENT) THAT AFFECTS THESE ENZYMES WILL AFFECT THE LEVELS OF THE STUDY DRUG IN THE BLOOD. THIS WILL PROVIDE INFORMATION TO HELP DECIDE WHICH MEDICATIONS CAN BE TAKEN SAFELY WITH THE STUDY DRUG. THE RESEARCH REQUIRES HEALTHY MALE AND FEMALE VOLUNTEERS AGED BETWEEN 18 AND 55. FEMALES MUST BE OF NON-CHILDBEARING POTENTIAL (STERILISED OR POST-MENOPAUSAL). THE STUDY WILL BE CONDUCTED AT A SPECIALIST CLINICAL TRIALS UNIT ON BEHALF OF A SPONSOR PHARMACEUTICAL COMPANY. PARTICIPATION WILL LAST APPROXIMATELY 32 - 64 DAYS AND WILL CONSIST OF 4 VISITS TO THE UNIT WITH A TOTAL OF 12 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/IEC01/4

• Date of REC Opinion

  15 Mar 2010

• REC opinion

  Further Information Favourable Opinion