Metabolic interaction study (induction/inhibition) of Icenticaftor.

• Research type

  Research Study

• Full title

  A Phase I, open-label, fixed-sequence, three-period study to evaluate the pharmacokinetics of icenticaftor (QBW251) when given alone and in combination with mefenamic acid or rifampicin in healthy participants.

• IRAS ID

  299592

• Contact name

  Devinda Weeraratne

• Contact email

  devinda.weeraratne@celerion.com

• Sponsor organisation

  Novartis Pharmaceuticals Corporation

• Eudract number

  2021-000299-12

• Duration of Study in the UK

  0 years, 3 months, 7 days

• Research summary

  The purpose of this study is to assess the effect of inhibition (via mefenamic acid) and induction (via rifampicin) on the blood levels of Icenticaftor in healthy participants. The results will provide guidance on the use of Icenticaftor in patients who are using other medications that may interact with it.
  Icenticaftor is being developed for patients with lung conditions like cystic fibrosis , bronchiectasis, and chronic obstructive pulmonary disease (COPD).
  

• REC name

  HSC REC B

• REC reference

  21/NI/0123

• Date of REC Opinion

  13 Sep 2021

• REC opinion

  Further Information Favourable Opinion