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Human ADME Study of [14C]-AZD1390

10. juni 2026 opdateret af: AstraZeneca

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

8

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Det Forenede Kongerige
      • Guildford, Det Forenede Kongerige, GU2 7WG
        • Research Site
      • Liverpool, Det Forenede Kongerige, L7 8XP
        • Research Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: AZD1390
Single dose of [14C]-AZD1390
Medicin: AZD1390
single dose

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Tidsramme: 6 Weeks
Amount excreted (Ae) (urine)
6 Weeks
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Tidsramme: 6 Weeks
Cumulative Amount excreted (CumAe) (urine)
6 Weeks
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Tidsramme: 6 Weeks
Amount excreted (Ae) (feaces)
6 Weeks
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Tidsramme: 6 Weeks
Cumulative Amount excreted (CumAe) (feaces)
6 Weeks
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Tidsramme: 6 Weeks
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
Tidsramme: 6 Weeks
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
Tidsramme: 6 Weeks
Amount (percentage) excreted (Fe) (urine)
6 Weeks
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Tidsramme: 6 Weeks
Cumulative Amount (percentage) excreted (CumFe) (urine)
6 Weeks
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Tidsramme: 6 Weeks
Amount (percentage) excreted (Fe) (feaces)
6 Weeks
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Tidsramme: 6 Weeks
Cumulative Amount (percentage) excreted (CumAe) (feaces)
6 Weeks
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Tidsramme: 6 Weeks
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
Tidsramme: 6 Weeks
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
Tidsramme: 6 Weeks
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
Tidsramme: 6 weeks
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
Tidsramme: 6 weeks
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
Tidsramme: 6 weeks
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
Tidsramme: 6 weeks
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
Tidsramme: 6 weeks
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
Tidsramme: 6 weeks
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
Tidsramme: 6 weeks
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
Tidsramme: 6 weeks
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
Tidsramme: 6 weeks
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
Tidsramme: 6 weeks
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
Tidsramme: 6 weeks
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
Tidsramme: 6 weeks
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
Tidsramme: 6 weeks
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
Tidsramme: 6 weeks
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
Tidsramme: 6 weeks
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
Tidsramme: 6 weeks
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
Tidsramme: 6 weeks
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
Tidsramme: 6 weeks
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
Tidsramme: 6 weeks
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
Tidsramme: 6 weeks
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
Tidsramme: 6 weeks
Analysis of urine: Cumulative amount excreted (CumAe)
6 weeks
Pharmacokinetic(s) of AZD1390 after a single oral dose
Tidsramme: 6 weeks
Analysis of urine: Fraction (percentage) excreted (Fe)
6 weeks
The distribution of total radioactivity into blood cells after a single oral dose
Tidsramme: 6 weeks
Analysis of urine: Fraction (percentage) excreted (Fe)
6 weeks
Pharmacokinetic(s) of AZD1390 after a single oral dose
Tidsramme: 6 weeks
Analysis of urine: Cumulative fraction (percentage) excreted (CumFe)
6 weeks
Pharmacokinetic(s) of AZD1390 after a single oral dose
Tidsramme: 6 weeks
Analysis of urine: Renal clearance (CLR)
6 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The phamrmacokinetic(s) of AZD1390 metabolite
Tidsramme: 6 weeks
Analysis of plasma: Maximum observed concentration (Cmax)
6 weeks
The phamrmacokinetic(s) of AZD1390 metabolite
Tidsramme: 6 weeks
Analysis of plasma: Area under the concentration-time curve from zero to infinity (AUCinf)
6 weeks
The phamrmacokinetic(s) of AZD1390 metabolite
Tidsramme: 6 weeks
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
Tidsramme: 6 weeks
Analysis of plasma: Time to reach maximum observed plasma concentration (Tmax)
6 weeks
The phamrmacokinetic(s) of AZD1390 metabolite
Tidsramme: 6 weeks
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
Tidsramme: 6 weeks
Analysis of plasma: Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
6 weeks
The phamrmacokinetic(s) of AZD1390 metabolite
Tidsramme: 6 weeks
Analysis of plasma: Apparent volume of distribution at steady state following extravascular administration (Vss/F)
6 weeks
The phamrmacokinetic(s) of AZD1390 metabolite
Tidsramme: 6 weeks
Analysis of plasma: Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)
6 weeks
The phamrmacokinetic(s) of AZD1390 metabolite
Tidsramme: 6 weeks
Analysis of metabolite in plasma: parent ratio
6 weeks
Metabolic profiling following single oral dose of AZD1390
Tidsramme: 6 weeks
Quantification and identification of major metabolites of AZD1390 in plasma and excreta.
6 weeks
The safety of a single dose of AZD1390
Tidsramme: 6 weeks
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
Tidsramme: 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.
6 weeks
The safety of a single dose of AZD1390
Tidsramme: 6 weeks
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
Tidsramme: 6 weeks
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
Tidsramme: 6 weeks
Assessment of weight (measurement units can be variable) throughout the study.
6 weeks
The safety of a single dose of AZD1390
Tidsramme: 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.
6 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AstraZeneca

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

30. juni 2026

Primær færdiggørelse (Anslået)

12. april 2028

Studieafslutning (Anslået)

12. april 2028

Datoer for studieregistrering

Først indsendt

18. december 2025

Først indsendt, der opfyldte QC-kriterier

10. juni 2026

Først opslået (Faktiske)

12. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • D6940C00006

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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-delingsadgangskriterier

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-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner