Multiple Dose, Crossover Food Effect Study of Oral Testosterone

  • Research type

    Research Study

  • Full title

    Randomised, Multiple-Dose, Crossover Food Effect Study of Oral Testosterone Undecanoate Capsule Product in Hypogonadal Men

  • IRAS ID

    193337

  • Contact name

    Adrian/J Stewart

  • Contact email

    adrian.stewart@celerion.com

  • Sponsor organisation

    Solural Pharma ApS

  • Eudract number

    2015-004489-27

  • Duration of Study in the UK

    0 years, 5 months, 12 days

  • Research summary

    The primary purpose of this study is to define the dose levels and capsule strengths of Testosterone Undecanoate to be used in the Clinical Phase 3 studies based on the FDA guidance for Cmax and Cavg testosterone levels at steady state under both fed (with food) and fasting conditions (without food). The Clinical Trial will be conducted at one centre in the UK and one in the USA , and will involve 32 hypogonadal male participants.

  • REC name

    HSC REC A

  • REC reference

    15/NI/0237

  • Date of REC Opinion

    27 Nov 2015

  • REC opinion

    Unfavourable Opinion