Study to Investigate 14C Fx-1006A

• Research type

  Research Study

• Full title

  A Phase I Study to Investigate the Absorption Metabolism and Excretion of 14C-Fx-1006A in Healthy Male Subjects Following a Single Oral Dose of 20 mg Fx-1006A Containing 50 µCi 14C-Fx-1006A.

• IRAS ID

  17949

• Sponsor organisation

  FoldRx Pharmacueticals Inc

• Eudract number

  2008-007882-21

• ISRCTN Number

  1

• Research summary

  Fx-1006A is new compound being developed for the treatment of amyloidosis. This study will assess the absorption, metabolism and elimination of Fx-1006. The study will also assess the safety and tolerability of FX-1006. A screening visit will be conducted to determine if the volunteer is eligible. This will be conducted from -14 days to -2 days before the first dose of study drug. If eligible the volunteers will enter the study and will receive single oral dose of 20 mg Fx-1006A Containing 50 æCi 14C-Fx-1006A. Volunteers will be required to stay in the clinical unit for a minimum of 16 nights and a maximum of 23 nights. The duration of stay is dependant on the amount of radioactivity recovered by Day 16. If less than 90% is recovered volunteers will be required to remain in house for a maximum additional 7 days. Blood, urine and faecal samples will be taken from volunteers to assess the systemic exposure of Fx-1006. Metabolites of Fx-1006 will also be determined from selected blood, urine and faecal samples during the study. Assessments of blood pressure and ECG will also be made at pre-determined points during the study. A follow-up visit will be conducted between Day 16 and Day 23 (depending on day of discharge).

• REC name

  Wales REC 1

• REC reference

  09/WSE04/8

• Date of REC Opinion

  16 Mar 2009

• REC opinion

  Further Information Favourable Opinion