KBT012 (QBR110530)

• Research type

  Research Study

• Full title

  THE DISPOSITION OF RADIOACTIVITY AND METABOLISM OF EPROTIROME IN HEALTHY SUBJECTS FOLLOWING ORAL ADMINISTRATION OF 14C EPROTIROME

• IRAS ID

  90050

• Contact name

  Philip Evans

• Sponsor organisation

  Karo Bio AB

• Eudract number

  2011-003774-83

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  Eprotirome is a drug currently under investigation for its potential in treating hyperlipidemia, a condition where there are high levels of lipids (fats) in the blood. It is specifically intended for patients suffereing from inherited high cholesterol. It works in the liver, and effectively lowers blood lipids but at doses low enough not to affect the heart or bones.This study is an open label, single dose design with the option to extend the study to a second part. In the first part of the study, seven subjects will be given an oral dose of [14C]-eprotirome (which is radiolabelled in a specific part of the drug). Blood, urine and faeces samples will be analysed for radioactivity, parent drug substance and drug metabolites (parts of the drug as it is broken down). Only the first part of the study will be performed, unless metabolites can be identified from a specific location in the structure of the drug, or if total recovery of radioactivity is low. In this case the second part of the study will be initiated and an additional seven subjects will be dosed with [14C]-eprotirome, which will be radiolabelled in a different part of the drug to the first part of the study.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  11/EE/0418

• Date of REC Opinion

  21 Nov 2011

• REC opinion

  Further Information Favourable Opinion