Human ADME Study of [14C]-Ceralasertib (AZD6738) and Absolute Bioavailability of Ceralasertib

Summary

This is an open-label, two-part study in participants with solid tumours and will be conducted at multiple study sites. Participants will be assessed for study eligibility prior to admission to the study site. Participants may be enrolled in either Part A or Part B of the study or in both. Part A will assess the absolute bioavailability, determine the excretory routes of \[14C\]-Ceralasertib, and evaluate the PK parameters of a Ceralasertib oral dose and a radiolabelled IV microdose of \[14C\]-Ceralasertib. Participants will be admitted to the study site pre-dose Part A and will remain at the study site for excreta (urine and faeces) collections, PK sampling and safety assessments. A washout period days will be observed between dosing in Part A and Part B if participants are taking part in both parts of the study. Part B will assess the ADME of \[14C\]-Ceralasertib. Participants will be readmitted to the study site for Part B and will remain at the study site for excreta (urine, faeces, and any vomitus) collections, PK sampling, and safety assessments. Participants will return to the study site for a Follow-up Visit after the last dose of Ceralasertib which will include routine safety assessments. After the completion of Parts A and/or B, and following the Follow-up Visit, participants may be allowed further access to Ceralasertib if in the opinion of the investigator they may derive clinical benefit.

Timeline

Start

2025-09-22

Primary completion

2025-10-21

Completion

2025-10-21

Outcome

Outcome not reported

Stopped (Business): “A decision, based solely on business strategy, was taken to terminate study D533BC00002 on 22 December 2025, as the clinical development programme for ceralasertib has been discontinued.”

Drugs

Indications