Phase 1 ADME study of 14C-Ibrexafungerp in healthy subjects(QSC202765)

• Research type

  Research Study

• Full title

  A Phase 1, Open-Label, Single-Centre Study to Evaluate the Absorption, Distribution, Metabolism, and Excretion (ADME) of Oral [14C]-Ibrexafungerp in Healthy Male Subjects

• IRAS ID

  271711

• Contact name

  David Angulo

• Contact email

  david.angulo@scynexis.com

• Sponsor organisation

  Scynexis Inc.

• Eudract number

  2019-003530-16

• Duration of Study in the UK

  0 years, 0 months, 23 days

• Research summary

  The sponsor is developing the test medicine, ibrexafungerp (also known as SCY-078), for the treatment and prevention of fungal infections. In humans, fungal infections occur when an invading fungus (a type of small organism) takes over an area of the body and is too much for the immune system to handle.
  The study will try to identify how ibrexafungerp is absorbed (taken up), distributed, metabolised (broken down) and eliminated (removed) from the body. The safety and tolerability of the study drug will also be investigated.

  The study is an open-label study involving 6 healthy male volunteers. The volunteers will receive a single dose of the radiolabelled test medicine ([14C]-ibrexafungerp) as an oral solution. ‘Radiolabelled’ means that the study drug has a radioactive component which enables researchers to track where the test medicine is in the body.
  The volunteers will attend the clinic for a minimum of 9 days (Day -1 to Day 8). It is planned that volunteers will be released as a group following study-related procedures on Day 8. However, the volunteers stay may be extended up to a maximum of 48 h (Day 10) if volunteers do achieve the release criteria (the radioactivity is still high in volunteer samples).

  If the criterion is still not met by Day 10, or if additional residency is not considered appropriate or necessary, then home collections of urine and/or faeces may be requested at the discretion of the investigator for individual subjects to a maximum of Day 20.

• REC name

  HSC REC A

• REC reference

  19/NI/0191

• Date of REC Opinion

  28 Oct 2019

• REC opinion

  Favourable Opinion