SEP-083-002

• Research type

  Research Study

• Full title

  A Microdose Study to Describe the Intravenous Pharmacokinetics of Early Development Candidates in Healthy Male and Female Subjects

• IRAS ID

  90166

• Contact name

  Stuart J Mair

• Sponsor organisation

  Sunovion Pharmaceuticals Inc

• Eudract number

  2011-004619-22

• Research summary

  The drug substances SEP-0364447, SEP-0362993, and SEP-0363431 (active ingredients [14C]-SEP-0364447, [14C]-SEP-0362993 and [14C]-SEP-0363431) will be administered as 15 minute infusions directly into the vein. The substances have not been administered to humans before. They act on the H3 receptor in the brain.The study is part of the development of a product that could potentially enhance the treatment of impaired thinking, often experienced in persons with schizophrenia (severe chronic psychiatric condition).

• REC name

  Scotland A REC

• REC reference

  11/IE/0159

• Date of REC Opinion

  27 Oct 2011

• REC opinion

  Further Information Favourable Opinion