Mass Balance and AME Study of 14C-labelled SPN-810M (QBR114072)

• Research type

  Research Study

• Full title

  An Open-Label, Single-Dose, Mass-Balance Study to Assess the Absorption, Metabolism, and Excretion (AME) of 14C Labeled SPN-810M (Molindone) in Healthy Adult Male Volunteers

• IRAS ID

  138907

• Sponsor organisation

  Supernus Pharmaceuticals Inc

• Eudract number

  2013-003338-34

• ISRCTN Number

  NCT02023606

• Research summary

  The Sponsor is developing the study drug, Molindone (also known as SPN-810M) for the potential treatment of impulsive aggression in children with attention deficit hyperactivity disorder (ADHD).

  The purpose of the study is to look at how radiolabelled (containing a small amount of radioactivity) Molindone is taken up broken down and removed from the body when given as a solution to be taken orally.

  During the study visit up to 7 healthy male volunteers will receive a single dose of 50 mg 14C Molindone.

• REC name

  Wales REC 1

• REC reference

  13/WA/0313

• Date of REC Opinion

  11 Oct 2013

• REC opinion

  Further Information Favourable Opinion