PK and Bioavailability of Testosterone Undecanoate (QBR116436)

• Research type

  Research Study

• Full title

  Study in Healthy Subjects to Investigate the Pharmacokinetics and Regional Bioavailability of Testosterone Undecanoate when Delivered Orally as a Divided Dose and when Delivered to Different Sites Within the Gastrointestinal Tract

• IRAS ID

  142250

• Contact name

  Pui Leung

• Contact email

  Pui.Leung@quotientclinical.com

• Sponsor organisation

  AbbVie Deutschland GmbH & Co KG

• Eudract number

  2013-003987-29

• ISRCTN Number

  To be registered

• Research summary

  The study drug, Testosterone Undecanoate, is currently available in the UK as the marketed product Restandol Testocaps™ 40 mg capsule, and is indicated as a testosterone replacement therapy in males with hypogonadal disorders. It acts as a replacement therapy for males with reduced natural levels of testosterone.

  The purpose of the study is to measure the amount of Testosterone and Testosterone Undecanoate (TU) in the blood when it is given orally (by mouth) from a capsule compared to delivery via a special capsule (Enterion™ capsule) that releases study drug into different parts of the gut.

  The study will consist of 4 study periods involving 1 group of 12 healthy male subjects. Each subject will receive the following 4 regimens (1 regimen per study period):
  Regimen A: TU as immediate release (IR) oral capsules;
  Regimen B: TU as IR capsules administered at set intervals;
  Regimen C: TU set to be released to the distal small bowel via the Enterion capsule;
  Regimen D: TU set to be released to the colon via the Enterion capsule.

• REC name

  Wales REC 2

• REC reference

  13/WA/0349

• Date of REC Opinion

  15 Nov 2013

• REC opinion

  Favourable Opinion