Phase 1 ADME Study of Defactinib in Healthy Male Subjects (QCL117453)

• Research type

  Research Study

• Full title

  A Phase 1, Open-Label Study of the Absorption, Metabolism and Excretion of Defactinib (VS-6063) in Healthy Male Subjects

• IRAS ID

  184314

• Contact name

  Mahesh Padval

• Contact email

  mpadval@verastem.com

• Sponsor organisation

  Verastem, Inc.

• Eudract number

  2015-002709-12

• Duration of Study in the UK

  0 years, 0 months, 24 days

• Research summary

  The Sponsor is developing the study drug, defactinib (VS-6063), for the potential treatment of cancer.

  This study will look at the way the study drug is taken up, processed and removed by the body. The safety and tolerability of the study drug will also be assessed.

  The study will consist of a single study period involving up to 6 healthy male subjects. Each subject will receive a single 400mg oral dose of radiolabelled [14C]-defactinib suspension, following an overnight fast. Subjects will then remain in the clinical unit for assessment until Day 8, or earlier if study requirements have been met.

• REC name

  Wales REC 2

• REC reference

  15/WA/0193

• Date of REC Opinion

  6 Aug 2015

• REC opinion

  Further Information Favourable Opinion