Mass balance study of 14C-ALS-008176 in healthy subjects (QBR117356)

• Research type

  Research Study

• Full title

  A Phase 1, Open-Label Study of the Absorption, Metabolism, Excretion and Absolute Bioavailability of 14C-ALS-008176 in Healthy Male Subjects

• IRAS ID

  159755

• Contact name

  Suzanne Sweet

• Contact email

  suzanne.sweet@quotientclinical.com

• Sponsor organisation

  Alios BioPharma

• Eudract number

  2014-002452-34

• Clinicaltrials.gov Identifier

  NCT02231671

• Research summary

  The Sponsor is developing the study drug, ALS-008176, for the potential treatment of respiratory syncytial virus which causes chest infections.

  The study will try to identify the way the body absorbs, breaks down and then removes the study drug.

  The study will consist of 2 parts involving 12 healthy male subjects. In Part 1, 6 subjects will receive an oral dose of 500 mg ALS-008176 followed by a dose of 100 µg [14C]-ALS-008112 intravenously (into a vein)

  In Part 2, 6 subjects will receive an oral dose of 375 mg [14C]-ALS-008176.

• REC name

  HSC REC A

• REC reference

  14/NI/1049

• Date of REC Opinion

  5 Aug 2014

• REC opinion

  Favourable Opinion