Metabolim and Elimination of [14C]-RUS351

• Research type

  Research Study

• Full title

  A Phase I Study to Investigate the Metabolism and Elimination of [14C]-RUS351 in Healthy Male Subjects Following a Single Oral Administration of RUS351 Containing 100 µCi [14C]-RUS351

• IRAS ID

  14159

• Sponsor organisation

  Cambridge Laboratories Ireland

• Eudract number

  2008-008223-15

• ISRCTN Number

  1

• Research summary

  RUS 351 has a similar structure to a chemical known as cis-dihydrotetrabenazine (HTBZ). HTBZ is the main active breakdown product of a chemical known as tetrabenazine (TBZ) which is responsible for reducing the amount of substances, known as monoamines, in the central nervous system. Animal studies have revealed that RUS351 has potentially antipsychotic properties and human studies have revealed that this drug has been well tolerated at doses of up to 100 mg.The purpose of this study is to find out how the study drug ([14C]-RUS351) is taken up by and eliminated from the body. A second purpose is to determine what the side effects are after a single oral dose of 50 mg of [14C]-RUS351.The study medication subjects will take has a radioactive substance built into the study drug ([14C]-RUS351). This will help us to find out how much of the study drug gets into subjects blood and how much passes from the body into the urine and faeces. The radiation (100 æCi) subjects will receive during this study is equivalent to approximately 5.3-month exposure to the natural background radiation which has been approved by the Administration of Radioactive Substances Advisory Committee (ARSAC).

• REC name

  Wales REC 2

• REC reference

  09/WSE02/2

• Date of REC Opinion

  21 Jan 2009

• REC opinion

  Further Information Favourable Opinion