Human ADME study of [14C]-AZD1390
Research type
Research Study
Full title
A Phase I, Open-label Study to Assess the Absorption, Distribution, Metabolism, and Excretion (ADME) of AZD1390 After a Single Oral Dose of [14C]-AZD1390 in Participants with Advanced Solid Malignancies
IRAS ID
1011316
Contact name
Roser Sanz Casañas
Contact email
Sponsor organisation
ASTRAZENECA FARMACÉUTICA SPAIN, S.A
Research summary
This study is being conducted to learn more about the absorption, distribution, metabolism, and excretion of the radio-labelled investigational drug, [14C]-AZD1390 in participants with Advanced Solid Malignancies (tumours).
When the deoxyribonucleic acid (DNA) in our cells is damaged by radiation, a protein called ataxia telangiectasia mutated (ATM) helps repair the damage. In aggressive brain tumours like glioblastoma (GBM), ATM is often very active, which helps the tumour survive radiation therapy. AZD1390 is a new drug being developed for patients with GBM. It works by specifically reducing the activity of ATM, while having little effect on similar enzymes. By doing this, AZD1390 may make tumour cells more vulnerable to radiation therapy.
In previous studies of AZD1390, the most frequent and related side effects to AZD1390 were: nausea, fatigue, diarrhoea, vomiting, and abnormal laboratory test findings.
Participants will take part in the study for approximately 6 weeks and will involve a stay at the study site/hospital for 8 days.
About 8 patients will take part in the study at 2 hospitals in the UK.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
25/SC/0072
Date of REC Opinion
1 May 2025
REC opinion
Further Information Favourable Opinion