ADME and PK of BI-409306 as oral solution in healthy males (117381)

• Research type

  Research Study

• Full title

  Metabolism and pharmacokinetics of [14C]-BI 409306 after administration of 25 mg [14C]-BI 409306 as oral solution in healthy male volunteers

• IRAS ID

  184402

• Contact name

  Holger Schmitt

• Sponsor organisation

  Boehringer Ingleheim Pharma GmbH & Co. KG

• Eudract number

  2015-001877-42

• Duration of Study in the UK

  0 years, 2 months, 1 days

• Research summary

  The Sponsor is developing the study drug, BI-409306, for the treatment of Alzheimer’s disease and the treatment of Cognitive Impairment (problems with thinking and understanding) associated with Schizophrenia.

  The purpose of this study is to look at the way BI 409306 is taken up, broken down and removed from the body when given as a radiolabelled oral solution (by mouth).

  The study will consist of 1 study part involving up to 10 healthy male subjects.
  On the morning of day 1 subjects will be asked to swallow an oral drinking solution containing 25mg of the study drug. The dosing container will be rinsed twice to ensure all of the solution has been consumed. Subjects will receive 240ml of fluid during dosing. The dose of the study drug will be radiolabelled with carbon-14, allowing the study team to trace the study drug in the body and assess how much is taken up and broken down by the body.

• REC name

  HSC REC B

• REC reference

  15/NI/0153

• Date of REC Opinion

  28 Aug 2015

• REC opinion

  Further Information Favourable Opinion