*276HV103 - Effect of Itraconazole and Phenytoin on BIIB113, and the Effect of BIIB113 on Midazolam

• Research type

  Research Study

• Full title

  A Phase 1, Open-Label, Fixed-Sequence, Crossover Study to Investigate the Effect of Itraconazole (CYP3A Inhibitor) and Phenytoin (CYP3A Inducer) on BIIB113 and the Effect of BIIB113 on Midazolam (CYP3A Substrate) in Healthy Participants.

• IRAS ID

  1007834

• Contact name

  Matthew Stagray

• Contact email

  clinicaltrials@biogen.com

• Sponsor organisation

  Biogen Idec Research Limited

• Research summary

  The study medicine (BIIB113) is an experimental treatment for Alzheimer’s disease (AD), a progressive serious condition that affects the brain. AD causes problems with memory and speech.
  People with AD have a toxic build-up of proteins in the brain, which form tangles. This causes cells in the brain to die and parts of the brain are damaged. We hope that BIIB113 will work by reducing the build-up of protein tangles in the brain, and by doing so, treat the underlying cause of AD and slow the onset of severe symptoms.

  Three approved drugs, Itraconazole, Phenytoin and Midazolam will also be used in this study. The purpose of this research study is to determine how BIIB113, interacts with these three approved drugs.
  The study has 3 parts and will be conducted in healthy participants aged 18-65.

  Part A will involve 24 participants and will look at how Itraconazole decreases the action of BIIB113. Part A will involve a inpatient stay of 17 nights. BIIB113 (capsules) will be given on two days and Itraconazole (oral solution) will be given on ten days.

  Part B will involve 24 participants and will look at how Phenytoin increases the action of BIIB113. Part B will involve a inpatient stay of 21 nights. BIIB113 (capsules) will be given on two days and Phenytoin (capsules) will be given three times a day on fourteen days.

  Part C will involve 22 participants and will look at how BIIB113 affects the action of Midazolam. Part C will involve a inpatient stay of 16 nights. BIIB113 (capsules) will be given on fourteen days and Midazolam (oral mucosal solution) will be given on two days.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  23/NW/0118

• Date of REC Opinion

  21 Aug 2023

• REC opinion

  Further Information Favourable Opinion