Effect of Ceralasertib on Pharmacokinetics of 3 Probe Substrates
Research type
Research Study
Full title
A Phase I, Open-label, Fixed-sequence Study to Evaluate the Effect of Ceralasertib on Pharmacokinetics of Probe Substrates for BCRP, CYP3A4, and OATP1B1 by Dosing of Rosuvastatin, Midazolam, and Pravastatin in Participants with Advanced Solid Tumours
IRAS ID
1011357
Contact name
David Johnson
Contact email
Sponsor organisation
AstraZeneca AB
Clinicaltrials.gov Identifier
Research summary
Researchers are looking for a better way to treat advanced solid tumors. In people with cancer, the body is not able to control the growth of some cells. The extra cells can form tumors. A solid tumor is a type of cancer that starts in an organ of the body. Advanced usually means that the cancer has spread within the organ where it started or to the nearby areas or to other parts of the body away from where it started.\nThe trial drug ceralasertib is designed to damage the DNA of the tumor cells. This causes the tumor cells to die. Researchers think that ceralasertib may help people who have advanced solid tumors. But, before ceralasertib can be approved as a standard treatment, researchers need to learn more about how it moves through the body and how it might interact with certain non-cancer medications. \nThe non-cancer medications that participants will take in this trial are rosuvastatin, pravastatin, and midazolam. Rosuvastatin and pravastatin are approved medications that are used to treat high cholesterol and prevent heart disease. Midazolam is a drug that doctors prescribe to put patients to sleep before surgeries or to help people who have trouble sleeping.\nThis trial will include up to about 24 participants between 18 and 65 years of age in about 4 sites within the United Kingdom and Spain.\nDuring the treatment period of the trial, participants will take ceralasertib, rosuvastatin, pravastatin, and midazolam on certain days. Ceralasertib, rosuvastatin, and pravastatin are taken as tablets by mouth. Midazolam is taken as a liquid by mouth. \nAfter participants complete the follow-up visit, some may continue taking ceralasertib for as long as it is needed, if the trial doctor suggests that it may provide benefit. \nThe Sponsor of the study is AstraZeneca AB.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
25/EE/0039
Date of REC Opinion
18 Mar 2025
REC opinion
Further Information Favourable Opinion