Study investigating the potential DDI of INE963 and KAE609 and FE on PK in healthy volunteers

• Research type

  Research Study

• Full title

  A Phase I, open-label, two-part, fixed sequence, three period crossover study to investigate the drug-drug interaction potential of INE963 and KAE609 (Part A) administered together, and a two period crossover study to investigate the effect of food on pharmacokinetics and safety of INE963 (Part B), in healthy participants.

• IRAS ID

  1007303

• Contact name

  Sofia Braud-Perez

• Contact email

  sofia.braud-perez@novartis.com

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2023-000047-23

• Research summary

  This is an open-label study in about 30 healthy male and female subjects (18 to 55 years, 15 per study part), at a single centre.
  The main purpose is to assess the pharmacokinetics between single oral doses of INE963 and KAE609 (Part A) and to assess the effect of food on the pharmacokinetics of a single oral dose of INE963 (Part B). Pharmacokinetics refers to how the study medicine is taken up into and distributed throughout the body; broken down and finally removed from the body.
  Furthermore, the safety and tolerability following single oral dose of KAE609 and/or INE963 alone, and in combination (Part A) and of INE963 in fasted and fed conditions (Part B), will be evaluated.
  Both study parts consist of a screening period of up to 28 days, 3 or 2 treatment periods (including wash-out periods after dosing) of approximately 66 days in Part A and 57 days in Part B, an ambulatory End-of-Study visit 22 days after last dosing and a safety follow-up call 30 days after dosing.

  INE963 and KAE609 are being developed by Novartis for a combination treatment for malaria.
  INE963 and KAE609 have not been approved by health authorities for the treatment of patients. One first in human study with INE963 has been completed and 9 clinical studies with KAE609. INE963 and KAE609 are co-administered for the first time in this study.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  23/SC/0097

• Date of REC Opinion

  14 Sep 2023

• REC opinion

  Further Information Favourable Opinion