Absolute bioavailability of selumetinib (QCL117383)

• Research type

  Research Study

• Full title

  A Study to Assess the Absolute Bioavailability of a Single Oral Dose of Selumetinib with Respect to an Intravenous Microdose of [14C] Selumetinib in Healthy Male Volunteers

• IRAS ID

  160064

• Contact name

  Stuart Mair

• Contact email

  stuart.mair@quotientclinical.com

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2014-002993-35

• Clinicaltrials.gov Identifier

  NCT02238782

• Research summary

  The Sponsor is developing the study drug, selumetinib, for the potential treatment of solid tumours in cancer patients.

  The study will try to identify how much selumetinib is taken up by the body when dosed orally (by mouth) compared to when the study drug is given through an intravenous (IV) injection (into a vein). The dose given directly into the vein will be radiolabelled meaning that it contains a radioactive component in order to track where the drug is in the body.

  In the study 12 healthy male volunteers aged 18 to 65 years will receive a single oral dose of 75 milligrams selumetinib (3 x 25 mg capsules) followed by a 15 minute IV infusion of 80 micrograms [14C]-selumetinib.

• REC name

  HSC REC A

• REC reference

  14/NI/1071

• Date of REC Opinion

  29 Aug 2014

• REC opinion

  Favourable Opinion