Mass balance recovery and pharmacokinetics of 14C TZP-101

• Research type

  Research Study

• Full title

  An Open Label, Single-Dose, Study in Healthy Male Subjects Designed to Assess the Mass Balance Recovery and Pharmacokinetics of 14C TZP-101

• IRAS ID

  94628

• Contact name

  Philip Evans

• Sponsor organisation

  Norgine Ltd.

• Eudract number

  2011-002621-22

• Research summary

  The Sponsor is developing TZP-101 as an intravenous (directly into the vein) treatment for gastrointestinal hypomotility disorders (sluggish movement of ingested food in the gut). This study is being conducted to assess the mass balance and pharmacokinetics (how the drug is broken down in the blood) following a single dose of radiolabelled [14C]-TZP-101 when given as an intravenous infusion.

• REC name

  HSC REC B

• REC reference

  11/NI/0175

• Date of REC Opinion

  13 Jan 2012

• REC opinion

  Further Information Favourable Opinion