NAT-2017-01-Ph 1 paediatric PK study of NATESTO™ (testosterone gel)

• Research type

  Research Study

• Full title

  A multicenter, open label, variable dose, two arm pilot paediatric phase 1 PK study to evaluate testosterone nasal gel (4.5% w/w) in hypogonadal boys

• IRAS ID

  230186

• Contact name

  Syed Faisal Ahmed

• Contact email

  Faisal.Ahmed@glasgow.ac.uk

• Sponsor organisation

  Acerus Biopharma Inc.

• Eudract number

  2017-001012-11

• Clinicaltrials.gov Identifier

  NCT03345797

• Duration of Study in the UK

  1 years, 0 months, 1 days

• Research summary

  This research study is being conducted to test a testosterone replacement gel which is administered by a nurse nasally in hypogonadal boys. The study will measure blood levels of testosterone and other markers in the 12 hours following administration with various doses.

• REC name

  West of Scotland REC 1

• REC reference

  17/WS/0148

• Date of REC Opinion

  1 Aug 2017

• REC opinion

  Further Information Favourable Opinion