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NCT Number: NCT07643870

Human ADME Study of [14C]-AZD1390

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

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Key information

Conditions

Advanced Solid Malignancies Astrocytoma Glioblastoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Guildford, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD1390

Drug

single dose

Primary outcomes

  1. The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

    Time frame: 6 Weeks

    Amount excreted (Ae) (urine)

  2. The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

    Time frame: 6 Weeks

    Cumulative Amount excreted (CumAe) (urine)

  3. The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

    Time frame: 6 Weeks

    Amount excreted (Ae) (feaces)

  4. The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

    Time frame: 6 Weeks

    Cumulative Amount excreted (CumAe) (feaces)

  5. The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

    Time frame: 6 Weeks

    Amount excreted (Ae) (total - urine and feaces combined)

  6. The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

    Time frame: 6 Weeks

    Cumulative Amount excreted (CumAe) (total urine and feaces combined)

  7. The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

    Time frame: 6 Weeks

    Amount (percentage) excreted (Fe) (urine)

  8. The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

    Time frame: 6 Weeks

    Cumulative Amount (percentage) excreted (CumFe) (urine)

  9. The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

    Time frame: 6 Weeks

    Amount (percentage) excreted (Fe) (feaces)

  10. The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

    Time frame: 6 Weeks

    Cumulative Amount (percentage) excreted (CumAe) (feaces)

  11. The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

    Time frame: 6 Weeks

    Amount (percentage) excreted (Fe) (total urine and faeces combined)

  12. The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

    Time frame: 6 Weeks

    Cumulative Amount (percentage) excreted (CumFe) (total urine and faeces combined)

  13. The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

    Time frame: 6 Weeks

    If emesis occurs, vomitus will be analysed for total radioactivity

  14. Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose

    Time frame: 6 weeks

    Analysis of plasma: Maximum observed concentration (Cmax)

  15. Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose

    Time frame: 6 weeks

    Analysis whole blood: Maximum observed concentration (Cmax)

  16. Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose

    Time frame: 6 weeks

    Analysis of plasma: Area under the concentration-time curve from zero to infinity (AUCinf)

  17. Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose

    Time frame: 6 weeks

    Analysis of whole blood: Area under the concentration-time curve from zero to infinity (AUCinf)

  18. Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose

    Time frame: 6 weeks

    Analysis of plasma: Area under the concentration-time curve from zero to the last measurable concentration (AUClast)

  19. Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose

    Time frame: 6 weeks

    Analysis of whole blood: Area under the concentration-time curve from zero to the last measurable concentration (AUClast)

  20. Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose

    Time frame: 6 weeks

    Analysis of plasma: Time to reach maximum observed plasma concentration (Tmax)

  21. Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose

    Time frame: 6 weeks

    Analysis of whole blood: Time to reach maximum observed plasma concentration (Tmax)

  22. Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose

    Time frame: 6 weeks

    Analysis of plasma: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz )

  23. Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose

    Time frame: 6 weeks

    Analysis of whole blood: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz )

  24. Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose

    Time frame: 6 weeks

    Analysis of plasma: Apparent total body clearance of drug from plasma after extravascular administration (CL/F)

  25. Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose

    Time frame: 6 weeks

    Analysis of whole blood: Apparent total body clearance of drug from plasma after extravascular administration (CL/F)

  26. Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose

    Time frame: 6 weeks

    Analysis of plasma: Mean residence time of the unchanged drug in the systemic circulation (MRT)

  27. Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose

    Time frame: 6 weeks

    Analysis of whole blood: Mean residence time of the unchanged drug in the systemic circulation (MRT)

  28. Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose

    Time frame: 6 weeks

    Analysis of plasma: Apparent volume of distribution at steady state following extravascular administration (Vss/F)

  29. Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose

    Time frame: 6 weeks

    Analysis of whole blood: Apparent volume of distribution at steady state following extravascular administration (Vss/F)

  30. Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose

    Time frame: 6 weeks

    Analysis of plasma: Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)

  31. Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose

    Time frame: 6 weeks

    Analysis of whole blood: Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)

  32. Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose

    Time frame: 6 weeks

    Ratio of AUCinf of plasma AZD1390 relative to AUCinf of plasma total radioactivity

  33. Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose

    Time frame: 6 weeks

    Ratio of AUCinf of whole blood total radioactivity to AUCinf of plasma total radioactivity

  34. Pharmacokinetic(s) of AZD1390 after a single oral dose

    Time frame: 6 weeks

    Analysis of urine: Cumulative amount excreted (CumAe)

  35. Pharmacokinetic(s) of AZD1390 after a single oral dose

    Time frame: 6 weeks

    Analysis of urine: Fraction (percentage) excreted (Fe)

  36. The distribution of total radioactivity into blood cells after a single oral dose

    Time frame: 6 weeks

    Analysis of urine: Fraction (percentage) excreted (Fe)

  37. Pharmacokinetic(s) of AZD1390 after a single oral dose

    Time frame: 6 weeks

    Analysis of urine: Cumulative fraction (percentage) excreted (CumFe)

  38. Pharmacokinetic(s) of AZD1390 after a single oral dose

    Time frame: 6 weeks

    Analysis of urine: Renal clearance (CLR)

Secondary outcomes

  1. The phamrmacokinetic(s) of AZD1390 metabolite

    Time frame: 6 weeks

    Analysis of plasma: Maximum observed concentration (Cmax)

  2. The phamrmacokinetic(s) of AZD1390 metabolite

    Time frame: 6 weeks

    Analysis of plasma: Area under the concentration-time curve from zero to infinity (AUCinf)

  3. The phamrmacokinetic(s) of AZD1390 metabolite

    Time frame: 6 weeks

    Analysis of plasma: Area under the concentration-time curve from zero to the last measurable concentration (AUClast)

  4. The phamrmacokinetic(s) of AZD1390 metabolite

    Time frame: 6 weeks

    Analysis of plasma: Time to reach maximum observed plasma concentration (Tmax)

  5. The phamrmacokinetic(s) of AZD1390 metabolite

    Time frame: 6 weeks

    Analysis of plasma: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz )

  6. The phamrmacokinetic(s) of AZD1390 metabolite

    Time frame: 6 weeks

    Analysis of plasma: Apparent total body clearance of drug from plasma after extravascular administration (CL/F)

  7. The phamrmacokinetic(s) of AZD1390 metabolite

    Time frame: 6 weeks

    Analysis of plasma: Apparent volume of distribution at steady state following extravascular administration (Vss/F)

  8. The phamrmacokinetic(s) of AZD1390 metabolite

    Time frame: 6 weeks

    Analysis of plasma: Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)

  9. The phamrmacokinetic(s) of AZD1390 metabolite

    Time frame: 6 weeks

    Analysis of metabolite in plasma: parent ratio

  10. Metabolic profiling following single oral dose of AZD1390

    Time frame: 6 weeks

    Quantification and identification of major metabolites of AZD1390 in plasma and excreta.

  11. The safety of a single dose of AZD1390

    Time frame: 6 weeks

    Number of participants with AEs and SAEs and severity of AEs and SAEs (based on CTCAE v5).

  12. The safety of a single dose of AZD1390

    Time frame: 6 weeks

    Number of participants with laboratory abnormalities based on assessment of Haematology/Haemostasis (whole blood), Urinalysis (dipstick), Serology, Clinical chemistry (serum or plasma), Creatinine clearance.

  13. The safety of a single dose of AZD1390

    Time frame: 6 weeks

    Number of participants with abnormal ECG and measurement of heart rate, PR QRS, QT and QTcF intervals (in milliseconds)

  14. The safety of a single dose of AZD1390

    Time frame: 6 weeks

    Number of participants with abnormal vital signs based on assessment of body temperature, pulse rate, and blood pressure completed with automated devices.

  15. The safety of a single dose of AZD1390

    Time frame: 6 weeks

    Assessment of weight (measurement units can be variable) throughout the study.

  16. The safety of a single dose of AZD1390

    Time frame: 6 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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