Human ADME Study of [14C]-AZD1390

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

This is a Phase I, multicentre, single-dose, open-label study to assess the absorption, distribution, metabolism, and excretion of [14C]-AZD1390.

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Solid Malignancies
• Intervention / Treatment: Drug: AZD1390

Detailed Description

On Day 1, participants will receive one dose of [14C]-AZD1390 . Participants will be confined to the study site until Day 8.

Approximately 8 enrolled male and female participants will receive study intervention in order to achieve a minimum of 4 evaluable participants.

Participants in this study will contribute to essential knowledge that will support the development of AZD1390 as a potential treatment for GBM, a malignancy of high unmet need, while being exposed to a low level of immediate risk.

• Study Type: Interventional
• Enrollment (Estimated): 8
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• United Kingdom
  • Guildford, United Kingdom, GU2 7WG
    • Research Site
  • Liverpool, United Kingdom, L7 8XP
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants with Histologically or cytologically documented, locally advanced or metastatic solid tumour, excluding lymphoma, no active anticancer treatment,
• ECOG performance status of 0 or 1 with no deterioration over the 2 weeks,
• Predicted life expectancy ≥ 12 weeks,
• Adequate organ and marrow function,
• Creatinine clearance ≥ 50 mL/min,
• Regular bowel movements,
• No cancer-associated cachexia (weight loss).

Exclusion Criteria:

• History or presence of myopathy or raised CK > 5 × ULN at screening,
• History of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment,
• History or presence of clinically significant hepatic disease,
• History of epileptic disorder or any seizure history unrelated to tumour,
• History of MDS/AML or with features suggestive of MDS/AML,
• Predisposition to bleeding
• History of persisting (> 2 weeks) severe cytopenia
• Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection
• History of another primary malignancy
• Persistent toxicities (CTCAE Grade ≥ 2), excluding alopecia, caused by previous anticancer therapy,
• Spinal cord compression or brain metastases for at least 4 weeks

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AZD1390; Single dose of [14C]-AZD1390	Drug: AZD1390; single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose	Amount excreted (Ae) (urine)	6 Weeks
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose	Cumulative Amount excreted (CumAe) (urine)	6 Weeks
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose	Amount excreted (Ae) (feaces)	6 Weeks
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose	Cumulative Amount excreted (CumAe) (feaces)	6 Weeks
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose	Amount excreted (Ae) (total - urine and feaces combined)	6 Weeks
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose	Cumulative Amount excreted (CumAe) (total urine and feaces combined)	6 Weeks
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose	Amount (percentage) excreted (Fe) (urine)	6 Weeks
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose	Cumulative Amount (percentage) excreted (CumFe) (urine)	6 Weeks
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose	Amount (percentage) excreted (Fe) (feaces)	6 Weeks
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose	Cumulative Amount (percentage) excreted (CumAe) (feaces)	6 Weeks
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose	Amount (percentage) excreted (Fe) (total urine and faeces combined)	6 Weeks
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose	Cumulative Amount (percentage) excreted (CumFe) (total urine and faeces combined)	6 Weeks
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose	If emesis occurs, vomitus will be analysed for total radioactivity	6 Weeks
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose	Analysis of plasma: Maximum observed concentration (Cmax)	6 weeks
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose	Analysis whole blood: Maximum observed concentration (Cmax)	6 weeks
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose	Analysis of plasma: Area under the concentration-time curve from zero to infinity (AUCinf)	6 weeks
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose	Analysis of whole blood: Area under the concentration-time curve from zero to infinity (AUCinf)	6 weeks
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose	Analysis of plasma: Area under the concentration-time curve from zero to the last measurable concentration (AUClast)	6 weeks
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose	Analysis of whole blood: Area under the concentration-time curve from zero to the last measurable concentration (AUClast)	6 weeks
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose	Analysis of plasma: Time to reach maximum observed plasma concentration (Tmax)	6 weeks
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose	Analysis of whole blood: Time to reach maximum observed plasma concentration (Tmax)	6 weeks
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose	Analysis of plasma: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz )	6 weeks
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose	Analysis of whole blood: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz )	6 weeks
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose	Analysis of plasma: Apparent total body clearance of drug from plasma after extravascular administration (CL/F)	6 weeks
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose	Analysis of whole blood: Apparent total body clearance of drug from plasma after extravascular administration (CL/F)	6 weeks
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose	Analysis of plasma: Mean residence time of the unchanged drug in the systemic circulation (MRT)	6 weeks
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose	Analysis of whole blood: Mean residence time of the unchanged drug in the systemic circulation (MRT)	6 weeks
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose	Analysis of plasma: Apparent volume of distribution at steady state following extravascular administration (Vss/F)	6 weeks
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose	Analysis of whole blood: Apparent volume of distribution at steady state following extravascular administration (Vss/F)	6 weeks
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose	Analysis of plasma: Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)	6 weeks
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose	Analysis of whole blood: Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)	6 weeks
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose	Ratio of AUCinf of plasma AZD1390 relative to AUCinf of plasma total radioactivity	6 weeks
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose	Ratio of AUCinf of whole blood total radioactivity to AUCinf of plasma total radioactivity	6 weeks
Pharmacokinetic(s) of AZD1390 after a single oral dose	Analysis of urine: Cumulative amount excreted (CumAe)	6 weeks
Pharmacokinetic(s) of AZD1390 after a single oral dose	Analysis of urine: Fraction (percentage) excreted (Fe)	6 weeks
The distribution of total radioactivity into blood cells after a single oral dose	Analysis of urine: Fraction (percentage) excreted (Fe)	6 weeks
Pharmacokinetic(s) of AZD1390 after a single oral dose	Analysis of urine: Cumulative fraction (percentage) excreted (CumFe)	6 weeks
Pharmacokinetic(s) of AZD1390 after a single oral dose	Analysis of urine: Renal clearance (CLR)	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The phamrmacokinetic(s) of AZD1390 metabolite	Analysis of plasma: Maximum observed concentration (Cmax)	6 weeks
The phamrmacokinetic(s) of AZD1390 metabolite	Analysis of plasma: Area under the concentration-time curve from zero to infinity (AUCinf)	6 weeks
The phamrmacokinetic(s) of AZD1390 metabolite	Analysis of plasma: Area under the concentration-time curve from zero to the last measurable concentration (AUClast)	6 weeks
The phamrmacokinetic(s) of AZD1390 metabolite	Analysis of plasma: Time to reach maximum observed plasma concentration (Tmax)	6 weeks
The phamrmacokinetic(s) of AZD1390 metabolite	Analysis of plasma: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz )	6 weeks
The phamrmacokinetic(s) of AZD1390 metabolite	Analysis of plasma: Apparent total body clearance of drug from plasma after extravascular administration (CL/F)	6 weeks
The phamrmacokinetic(s) of AZD1390 metabolite	Analysis of plasma: Apparent volume of distribution at steady state following extravascular administration (Vss/F)	6 weeks
The phamrmacokinetic(s) of AZD1390 metabolite	Analysis of plasma: Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)	6 weeks
The phamrmacokinetic(s) of AZD1390 metabolite	Analysis of metabolite in plasma: parent ratio	6 weeks
Metabolic profiling following single oral dose of AZD1390	Quantification and identification of major metabolites of AZD1390 in plasma and excreta.	6 weeks
The safety of a single dose of AZD1390	Number of participants with AEs and SAEs and severity of AEs and SAEs (based on CTCAE v5).	6 weeks
The safety of a single dose of AZD1390	Number of participants with laboratory abnormalities based on assessment of Haematology/Haemostasis (whole blood), Urinalysis (dipstick), Serology, Clinical chemistry (serum or plasma), Creatinine clearance.	6 weeks
The safety of a single dose of AZD1390	Number of participants with abnormal ECG and measurement of heart rate, PR QRS, QT and QTcF intervals (in milliseconds)	6 weeks
The safety of a single dose of AZD1390	Number of participants with abnormal vital signs based on assessment of body temperature, pulse rate, and blood pressure completed with automated devices.	6 weeks
The safety of a single dose of AZD1390	Assessment of weight (measurement units can be variable) throughout the study.	6 weeks
The safety of a single dose of AZD1390	Number of participants with abnormal physical examination based on assessment of general appearance, respiratory, cardiovascular, abdomen, skin, head and neck, lymph nodes, thyroid, musculoskeletal, and neurological systems.	6 weeks

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): April 12, 2028
• Study Completion (Estimated): April 12, 2028

Study Registration Dates

• First Submitted: December 18, 2025
• First Submitted That Met QC Criteria: June 10, 2026
• First Posted (Actual): June 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Solid tumor; Glioblastoma; Malignancies; ADME; Single-dose; AZD1390; Radioactivity / radiation; Metabolite / metabolism; ATM kinase inhibitor
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neoplasms; Glioblastoma; AZD1390
• Other Study ID Numbers: D6940C00006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No