Disposition of [14C[-ACR16 in healthy subjects after single oral dose.

• Research type

  Research Study

• Full title

  The disposition of [14C]-ACR16 in healthy male subjects after single oral administration.

• IRAS ID

  24585

• Eudract number

  2009-013257-15

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  ACR16 is a compound under development for the treatment of symptoms of Huntington??s disease. The compound belongs to a class of therapeutic agents called dopaminergic stabilisers.Dopaminergic stabilisers have the ability to reverse both hypo as well as hyperdopaminergia in vivo. ACR16 is considered to have a state-dependent psychomotor stabilising activity in perturbed neurotransmission and is believed to restore disturbed functioning in these networks. Further development of ACR16 is required for which greater knowledge of the metabolism (breakdown) and excretion (elimination) in man is required. This healthy volunteer study aims to provide information on the levels of ACR16 in the blood and how the human body breaks down and eliminates ACR16. Six healthy men aged between 30 and 65 will participate and receive one oral dose, which will have a radiolabelled marker (carbon 14[14C]) attached. After taking [14C]-ACR16 all urine and faeces will be collected, from which it is possible to measure the eliminated Carbon 14. This will show how much of ACR16 is eliminated from the body in urine and in faeces. Once 90 % of the Carbon 14 has been recovered from subjects they will be allowed to go home but this will not be before 168 hours (Day 8) after dosing. The longest the subjects will stay in the clinic after dosing will be 216 hours (Day 10). However if the recovery of Carbon 14 is less than 90% subjects may be required to collect urine and or faeces at home for a further 4 days after discharge (up to Day 14 after dosing).As well as collecting urine and faeces, blood samples will be collected to measure the amount of ACR16 in the blood and plasma. Plasma will be also be analysed for breakdown products of ACR16, known as metabolites.

• REC name

  Scotland A REC

• REC reference

  09/IEC02/12

• Date of REC Opinion

  2 Jul 2009

• REC opinion

  Favourable Opinion