Dose-escalation Trial to assess selumetinib Safety,Tolerability & PK

• Research type

  Research Study

• Full title

  A Phase I, Single-centre, Open-label, Dose-escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of Selumetinib Given Orally in Japanese and Non-Japanese Asian Healthy Male Volunteers

• IRAS ID

  137670

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2013-003203-19

• ISRCTN Number

  not provided

• Research summary

  We are conducting a phase 1 clinical trial with a new medicine known as selumetinib at RPL clinical research unit. Selumetinib is a new medicine being developed for the treatment of cancer by Astrazeneca AB, a global pharmaceutical company who are the sponsors of the study.
  In cancer cells, certain signalling pathways (i.e. the process by which cells send chemical messages to each other) may become disregulated due to abnormal cell division. This may involve the activation of mutations in certain genes that have the potential to cause cancer. Inhibition of one of the signalling pathways known as the MEK pathway blocks the inappropriate signals and is anticipated to slow down cancer cell division and growth, offering a promising anti-cancer therapeutic strategy together with other anti-cancer medications.
  In order to gain marketing approval for selumetinib in Japan it must first be assessed in Japanese volunteers and Non-Japanese Asian volunteers. Previous data demonstrated that there is possibly a difference between Japanese and Western patients in how they absorb and break down the drug (pharmacokinetics, PK) this may lead to differences in blood levels of selumetinib. However due to the small numbers it is difficult to understand if there is a true difference. Therefore, there is a need for more data on selumetinib administration in these populations.
  This is the first study with selumetinib in healthy male Japanese and non-Japanese Asian volunteers. It is designed to assess the safety, tolerability and PK of selumetinib after single doses. Data from this study will be compared to data from previous selumetinib studies conducted in Western healthy volunteer and patient studies.
  Standard safety assessments including ECGs, vital signs, blood/urine safety tests, PK samples and monitoring of adverse events. An optional exploratory pharmacogenetic sample will be taken for future DNA analysis if volunteers sign a separate consent form.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  13/LO/1378

• Date of REC Opinion

  11 Oct 2013

• REC opinion

  Further Information Favourable Opinion