A study to assess CYP3A4 induction by OC000459

• Research type

  Research Study

• Full title

  An Open Label Study in Healthy Subjects to Evaluate the Potential for Cytochrome P450 3A4 Induction by Oral OC000459 Using Oral Midazolam as A Probe

• IRAS ID

  42483

• Contact name

  Salvatore Febbraro

• Sponsor organisation

  Oxagen Ltd

• Eudract number

  2009-017643-33

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  01056575

• Research summary

  The drug being tested in this study is called OC000459. It is being developed for the treatment of asthma and is expected to relieve some of the associated symptoms. Animal studies of OC000459 have shown that the drug is safe (only minor effects of no clinical relevance were seen following maximal doses). OC000459 has been tested in healthy volunteers as single and multiple oral doses and as an oral drinking suspension and was shown to be safe. OC000459 has also been tested in asthma patients as single and multiple oral doses and was shown to be safe and effective in reducing asthma symptoms. This study is to assess whether OC000459 has any effect on an enzyme called CYP3A4. The study will assess whether this enzyme continues to breakdown (metabolize) the substrate Midazolam as it would normally when OC000459 is not present. Another drug called Midazolam will be used as the material upon which the enzyme (CYP3A4) acts. The sponsor, Oxagen Ltd, will provide funding for this research. This is an open-label study (both subjects and researchers will know which treatment is being received) in a total of 20 healthy volunteers. The treatment period of the study consists of 10 over-night stays at Simbec (Day -1 until Day 10). Subjects will receive two single doses of Midazolan; the first on Day 1, and the second on Day 9 following 6.5 days of twice-daily dosing of OC000459 (Days 3 to 9). Blood samples will be collected in order to determine levels of OC000459 in the blood, as well as the levels of midazolam and its breakdown product (metabolite): 4-hydroxymidazolam. Other safety parameters will also be measured at pre-determined time-points during the study; these include blood pressure, pulse and 12-lead ECG. Adverse events will be monitored throughout.

• REC name

  Wales REC 2

• REC reference

  10/WSE02/7

• Date of REC Opinion

  12 Feb 2010

• REC opinion

  Favourable Opinion