Open Label AME study of Lu AG06474 following a single oral dosing of [14C]-Lu AG06474 to healthy men

• Research type

  Research Study

• Full title

  Interventional, open-label, single-dose trial investigating the absorption, metabolism, and excretion (AME) of Lu AG06474 following a single oral dosing of [14C]-Lu AG06474 to healthy men

• IRAS ID

  1010126

• Contact name

  Julie Berg Schmidt

• Contact email

  JUBG@lundbeck.com

• Sponsor organisation

  H. Lundbeck A/S (Lundbeck)

• Research summary

  The Study Drug (Lu AG06474) is an investigational drug being developed by the sponsor as a potential treatment for chronic pain, headache disorders, and migraine.
  As with other similar studies, Lu AG06474 will be radiolabeled (i.e., ‘tagged’) with a naturally occurring radioactive form of carbon (14C) to allow detection and measurement of the study drug and any breakdown products in the blood, urine and faeces.

  This trial is designed to investigate the mass balance, absorption, metabolism, and excretion of Lu AG06474 following the administration of a single oral dose to healthy men.

  Participants will be confined to the clinic from Day -1 until at least Day 5. Participants will be discharged from the clinic 96 hours post-dose on Day 5 if they fulfil both discharge criteria:
  - cumulatively ≥90% of the radioactive dose has been recovered in excreta (urine and feces)
  - <1% of the radioactive dose in combined excreta, daily, for two consecutive 24-hour sampling intervals

  More detail will be in the design section.

  Twelve healthy men are planned to be included in this trial.
  The total trial duration per participant from baseline to the end of trial will be maximum 24 days and maximum 51 days if the screening period is included.

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  24/EE/0109

• Date of REC Opinion

  23 Jul 2024

• REC opinion

  Further Information Unfavourable Opinion