A study of CYP 450 3A4 and 1A2 induction by ADC3680B

• Research type

  Research Study

• Full title

  An open-label study in healthy subjects to assess the potential for Cytochrome P450 3A4 and Cytochrome P450 1A2 induction by ADC3680B using oral midazolam and caffeine as probes

• IRAS ID

  70971

• Contact name

  Salvatore Febbraro

• Sponsor organisation

  Pulmagen Therapeutics LLP

• Eudract number

  2010-024369-27

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  A new drug called ADC3680B is being developed for the treatment of both asthma and allergic rhinitis (an allergic reaction that can cause cold-like symptoms, such as sneezing, itchiness and a blocked or runny nose e.g. Hayfever). ADC3680B works by acting on cells in the blood which are involved in allergic reactions and may help ease or stop them from occurring. The study will be conducted in a total of 20 healthy volunteers. The purpose of this study is to investigate the effects of ADC3680B on two important enzymes in the body; CYP 3A4 and CYP 1A2 (enzymes are small compounds which are responsible for the breakdown of drugs in the body). The drugs, midazolam and caffeine will be used to test whether these enzymes continue to work as they would normally when ADC3680B is present. Volunteers will reside in the Clinical Unit at Simbec from the afternoon of Day -1 until the morning of Day 17. Volunteers will receive a co-administered dose of midazolam and caffeine on the mornings of Day 1 and Day 16. ADC3680B will be administered every morning from Day 3 to Day 16. The study will assess the safety and blood levels of midazolam, caffeine and their break down products, as well as of ADC3680B. The safety of trial participants will be monitored by qualified and appropriately trained clinical staff throughout the study, and Subjects will not be discharged from the study until they have satisfied the research physician that they are fit and well to do so.

• REC name

  Wales REC 1

• REC reference

  11/WSE04/2

• Date of REC Opinion

  19 Jan 2011

• REC opinion

  Further Information Favourable Opinion