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Clinical Trials in the UK / NCT07643870
Starting soon Phase 1

Human ADME Study of [14C]-AZD1390

NCT07643870 · tracked via the Priya Life Science UK tracker
Sponsor
AstraZeneca
Phase
Phase 1
Started
2026-06-30
Last updated
2026-06-12

Condition(s) studied

Advanced Solid Malignancies

Investigational drug(s) / intervention(s)

AZD1390 →

AZD1390: single dose

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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

Primary outcome measure(s)

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

Trial sites (2)

FacilityCityRegionStatus
Research Site Guildford United Kingdom
Research Site Liverpool United Kingdom

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07643870 on ClinicalTrials.gov ↗ ← All trials in the UK