A Study of 14C-ADC3680 in Healthy Volunteers

• Research type

  Research Study

• Full title

  An open label, single-dose, study designed to assess the mass balance recovery, metabolite profile and metabolite identification of 14C-ADC3680 in healthy male subjects

• IRAS ID

  91550

• Contact name

  Pui Man Leung

• Sponsor organisation

  Pulmagen Therapeutics LLP

• Eudract number

  2011-005131-75

• ISRCTN Number

  1

• Research summary

  A new drug called ADC3680B is being developed for the treatment of asthma. ADC3680B works by acting on cells in the blood which are involved in allergic reactions and may help ease or stop them from occurring. The purpose of this study is to find out how the study drug (14C-ADC3680) is taken up by and eliminated from the body. The study drug has been combined with a radioactive substance called carbon-14 (14C). This will help us to find out how much of the study drug gets into the blood and how much passes from the body into urine and faeces. Volunteers will need to attend Simbec Research Ltd on 3 occasions; once for a screening visit, once for the treatment period and once for the study follow-up visit. The treatment period will involve volunteers staying in Simbec from the afternoon of Day -1 (the day before dosing) until the afternoon of Day 8 (including 8 overnight stays). Subjects will receive a single dose of 14C-ADC3680 on the morning of Day 1. If required, subjects will stay in the clinic for up to 3 further days after Day 8 until the radioactivity recovery level has been achieved. The safety of trial participants will be monitored by qualified and appropriately trained clinical staff throughout the study, and subjects will not be discharged from the study until they have satisfied the research physician that they are fit and well to do so.

• REC name

  Wales REC 2

• REC reference

  11/WA/0324

• Date of REC Opinion

  11 Nov 2011

• REC opinion

  Favourable Opinion