Bioavailability study comparing two formulations Lu AG06466

• Research type

  Research Study

• Full title

  Interventional, randomized, open-label, crossover, single-dose, relative bioavailability study comparing two pharmaceutical formulations of Lu AG06466 and investigating the food effect on Lu AG06466 in healthy subjects

• IRAS ID

  292825

• Contact name

  Samuel Israel

• Contact email

  Samuel.Israel@labcorp.com

• Sponsor organisation

  Lundbeck A/S (Lundbeck)

• Eudract number

  2020-000694-24

• Clinicaltrials.gov Identifier

  21/LO/0268, REC Ref

• Duration of Study in the UK

  0 years, 1 months, 24 days

• Research summary

  The purpose of this study is to compare the relative bioavailability of two different formulations (tablet versus capsule formulations) of the study drug Lu AG06466 and to also investigate the effect of food on the study drug in healthy participants.

  The study consists of 6 sequences with 4 periods in each sequence.
  The first 3 periods will be randomised. Each participant will receive the following four single dose treatments:
  •Lu AG06466 10 mg, capsule, fasted state
  •Lu AG06466 10 mg, tablet, fasted state
  •Lu AG06466 10 mg, tablet, fed state (high-fat meal)
  •Lu AG06466 10 mg, tablet, dosed in combination with 20 mL of the antacid Maalox (400 mg aluminium hydroxide and 800 mg magnesium hydroxide) administered 5 minutes pre dose and 35 minutes post dose in the fasted state

  In Period 4, all participants will be dosed with Lu AG06466 in combination with antacid.

  The antacid (Maalox [aluminium hydroxide and magnesium hydroxide]), will be administered 5 minutes before treatment with the Lu AG06466 tablet, and again 35 minutes after treatment with the Lu AG06466 tablet.

  Each Lu AG06466 dose administration will be separated by a washout period of at least 72 hours. Blood samples for plasma quantification of Lu AG06466 and metabolite Lu AG06988 will be collected up to 72 hours after each administration of Lu AG06466.

  In this study, a total of 18 healthy men or women will be enrolled, with 3 participants randomised to each sequence. Participants will be confined to the clinic from the Baseline Visit (Day -1) and remain there until discharge on Day 12. The total study duration per participant from baseline to the end of follow up will be approximately 3 weeks.
  

• REC name

  London - Brent Research Ethics Committee

• REC reference

  21/LO/0268

• Date of REC Opinion

  26 Jul 2021

• REC opinion

  Further Information Favourable Opinion