NOV-OL-DDI-KAF156 & LUM566

• Research type

  Research Study

• Full title

  A Phase I, open-label, fixed-sequence, two-period, crossover, drug-drug interaction study to evaluate the effect of multiple doses of ganaplacide and lumefantrine combination on the pharmacokinetics of midazolam, repaglinide, dextromethorphan, metformin, rosuvastatin and dolutegravir in healthy participants.

• IRAS ID

  308193

• Contact name

  Devinda Weeraratne

• Contact email

  devinda.weeraratne@celerion.com

• Sponsor organisation

  Novartis Pharmaceuticals Corporation

• Eudract number

  2021-000926-87

• Clinicaltrials.gov Identifier

  NCT05236530

• Duration of Study in the UK

  0 years, 2 months, 21 days

• Research summary

  A Phase I, open-label, fixed-sequence, two-period, crossover, drug-drug
  interaction study to evaluate the effect of multiple doses of ganaplacide and
  lumefantrine9approved drug) combination on the pharmacokinetics of midazolam(approved drug), repaglinide9approved drug), dextromethorphan(approved drug), metformin(approved drug), rosuvastatin(approved drug) and dolutegravir(approved drug) in healthy participants.
  Drug-drug interaction study of ganaplacide and lumefantrine with midazolam,
  repaglinide, dextromethorphan, metformin, rosuvastatin and dolutegravir.

• REC name

  HSC REC B

• REC reference

  21/NI/0184

• Date of REC Opinion

  11 Jan 2022

• REC opinion

  Further Information Favourable Opinion