To evaluate excretion, metabolism & pharmacokinetics of 14C-AZD 2423

• Research type

  Research Study

• Full title

  An Open-label, Single Dose, Phase I Study to Evaluate the Excretion of Radioactivity, the Metabolic Profile, Pharmacokinetics, Safety and Tolerability Following Single Oral Administration of [14C]AZD2423 to Healthy Male Volunteers

• IRAS ID

  65691

• Contact name

  Marianne Kasti

• Sponsor organisation

  AstraZeneca R&D

• Eudract number

  2010-020686-25

• Research summary

  The drug being tested in this study is AZD2423. It is being developed as a possible treatment for neuropathic pain and chronic obstructive pulmonary disease (COPD). Neuropathic pain is a type of pain which is caused by damage to or dysfunction of the nervous system. Chronic obstructive pulmonary disease (COPD) refers to chronic bronchitis and emphysema, a pair of two commonly co-existing diseases of the lungs in which the airways become narrowed. This leads to a limitation of the flow of air to and from the lungs causing shortness of breath. The primary objective of the study are: to investigate the rate, route and extent of excretion of radioactivity in urine and faeces following single oral administration of AZD [14C] 2423.In this study AZD2423 is joined with radioactive carbon. This allows us to track tiny quantities of the drug and its breakdown products and determine how long they remain in the body. By measuring the drug in faeces and urine we can determine how the drug is eliminated from the body. We may also want to investigate how genetic variations may influence the way subject responds to AZD2423.The study will take place at Quintiles Drug research Unit at Guy's Hospital, Quintiles Ltd. The study involves 3 visits to the research unit, with a pre-study screening visit and a post-study follow-up visit. The study is expected to involve a total of 6 healthy male volunteers. The study consists of three visits: enrolment visit (Visit 1), the residential period (Visit 2) and a follow-up visit (Visit 3). The information gained in this study will help the sponsor of this study to determine whether AZD2423 is suitable for further studies in humans.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  10/H0804/80

• Date of REC Opinion

  4 Nov 2010

• REC opinion

  Favourable Opinion