Interaction study itraconazole vs ganaplacide/lumefantrine combination

• Research type

  Research Study

• Full title

  A Phase I, open-label, fixed sequence, two-period, crossover, drug-drug interaction study to investigate the interaction potential of itraconazole on the pharmacokinetics of ganaplacide and lumefantrine combination in healthy participants

• IRAS ID

  303311

• Contact name

  Patrick Winiger

• Contact email

  patrick.winiger@celerion.com

• Sponsor organisation

  Novartis Pharmaceticals Corporation, USA

• Eudract number

  2021-000924-36

• Duration of Study in the UK

  0 years, 3 months, days

• Research summary

  The purpose of this study is to assess the effect of multiple doses of
  itraconazole, a strong (CYP3A4/5) enzyme inhibitor, on the effect of ganaplacide and
  lumefantrine in healthy participants. This study will provide information regarding possible drug interactions in future clinical studies with ganaplacide and lumefantrine. Ganaplacide and lumefantrine are drugs in development for malaria.

• REC name

  HSC REC B

• REC reference

  21/NI/0124

• Date of REC Opinion

  19 Aug 2021

• REC opinion

  Favourable Opinion