Multiple Dose, Crossover Study of Oral Testosterone Undecanoate

• Research type

  Research Study

• Full title

  Open-Label, Randomised, Multiple-Dose, Two-way Crossover Study of Oral Testosterone Undecanoate Capsule Product in Men with low Testosterone Levels\n\n

• IRAS ID

  197212

• 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, 4 months, 15 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 future Clinical studies based on the FDA guidance. Multiple doses of Testosterone Undecanoate will be administered orally 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 in total 32 participants with low testosterone levels, as defined by ≤ 3 ng/ml.\n\n

• REC name

  HSC REC B

• REC reference

  16/NI/0006

• Date of REC Opinion

  21 Jan 2016

• REC opinion

  Favourable Opinion