Human ADME Study of [14C]Adavosertib

• Research type

  Research Study

• Full title

  A Phase I, Open-Label, Non-Randomised Study of the Absorption, Distribution, Metabolism, and Excretion of Adavosertib After a Single Oral Dose of [14C]Adavosertib to Patients with Advanced Solid Tumour

• IRAS ID

  1003540

• Contact name

  Rocelyn DelCarmen

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2020-005390-27

• Research summary

  Human ADME (Absorption, Distribution, Metabolism, Excretion) study of radiolabelled adavosertib after a single oral dose.

  AstraZeneca is sponsoring this open-label study for adult patients with Advanced Solid Tumours.

  The study drug being tested is called radiolabelled adavosertib which means that the drug can be traced in the blood, urine, faeces and vomit (if presented) allowing researchers to identify how the study drug breaks down within the body.

  This study will help determine how safe and tolerable adavosertib is in treating patients with advanced solid tumours. It is also being tested to see how it works inside the body and how it is eliminated from the body as there is currently no complete data from human clinical trials on this.

  The objective of this study is to determine the importance of the kidney and liver in the breakdown of the study drug and its components. This will help researchers understand if the study drug dose will need to be altered in patients with kidney or liver impairments or if the study drug is likely to interact with other drugs.

  The study will be conducted in the United Kingdom; approximately 8 patients will be enrolled.

  Participants will be in the study for approximately 66 days consisting of:
  • Screening Period – determine whether patients are eligible to take part in the study.
  • Treatment Period – single dose of radiolabelled adavosertib will be administered orally.
  • Follow-up Period – may include two visits: End of Treatment Visit and End of Study Visit.

  Participants will undergo testing and procedures including, but not limited to signing an Informed Consent Form, providing medical history, undergoing an electrocardiogram test, giving blood, urine, faeces and vomit (if presented) samples.

  After study completion, patients may be considered to participate in a separate study to continue receiving adavosertib.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  21/LO/0173

• Date of REC Opinion

  4 May 2021

• REC opinion

  Further Information Favourable Opinion