ingle Dose ADME Study with 300 mg 14C-netupitant in healthy malesQuo

• Research type

  Research Study

• Full title

  An open label, single dose study in healthy male subjects designed to assess the mass balance recovery, pharmacokinetics, metabolite profile and metabolite identification of 300 mg 14C-netupitant

• IRAS ID

  59511

• Contact name

  Howard Goodall

• Sponsor organisation

  Helsinn Healthcare SA

• Eudract number

  2010-021859-16

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The drug that is under investigation during this study is netupitant, which is intended to be used as a treatment for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with cancer who are receiving chemotherapy treatment. The purpose of the study is to define the absorption, breakdown and excretion of a single dose of radiolabelled netupitant and its breakdown products by measuring their concentration in blood, urine and faeces over a 14 day period (-radiolabelled- means that the test drug has a radioactive component to help track the drug). The safety and tolerability of the test drug will also be assessed. Six healthy male subjects (with a maximum of three additional replacement subjects if necessary) between 30 and 60 years of age who meet the inclusion/exclusion criteria will participate in the study. The study consists of a screening visit and one dosing/in-patient observation period, during which the subjects will be resident for up to 15 nights. Subjects may, however, be discharged any time after Day 11 if the discharge criteria (defined in the protocol) has been met. If necessary, subjects may be asked to continue collecting urine and faecal samples at home following discharge if insufficient recovery has been achieved by 336 h after dosing. Each subject will receive one oral dose of 300 mg 14C-netupitant (carbon 14 is a radiolabelled marker). This will be administered by a syringe into the mouth of the volunteer. After taking the study drug, all urine and faeces will be collected and blood samples will be collected at regular intervals throughout the study duration. This study will be conducted at Quotient Clinical, Edinburgh.

• REC name

  Scotland A REC

• REC reference

  10/IEC02/21

• Date of REC Opinion

  2 Sep 2010

• REC opinion

  Further Information Favourable Opinion