Single Dose Study with 14C-A3309

• Research type

  Research Study

• Full title

  A Study to Investigate the Absorption, Distribution, Metabolism and Excretion of [14C]-A3309 Following Oral Administration to Healthy Male Volunteers Quotient Clinical Study Number:QCL-001262

• IRAS ID

  36335

• Contact name

  Stuart J Mair

• Sponsor organisation

  Albireo AB

• Eudract number

  2009-017345-67

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The drug that's under investigation during this study is A3309. This drug is expected to be used as a treatment for patients suffering from constipation. Constipation is a common condition that affects people of all ages. People who are constipated may find that their faeces (stools or bowel motions) become hard and difficult to pass. They may go to the toilet less often as the time between passing bowel motions often increases. People can also experience pain when passing a bowel motion and can suffer from abdominal (stomach) cramps, bloating and nausea (feeling sick). The purpose of this study is to define the rate of absorption, distribution, breakdown and excretion of a single dose of radiolabelled A3309 ([14C] A3309) and its breakdown products by measuring their concentration in blood, urine and faeces over a 10 day period. ??Radiolabelled? means that the test drug has a radioactive component to help us track the drug.6 healthy male volunteers between 30 and 60 years of age who meet the inclusion criteria will be enrolled in this study. This study consists of a screening visit and a dosing/in-patient observation period. Participation in this study from admission to discharge is approximately 10 days. During the in-patient observation period, volunteers are required to stay in the clinic. This study will be conducted at 1 centre in Edinburgh.Healthy volunteers will be recruited by advertising in papers, radio, websites and volunteer databases.

• REC name

  Scotland A REC

• REC reference

  09/IEC02/33

• Date of REC Opinion

  28 Jan 2010

• REC opinion

  Further Information Favourable Opinion