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Human ADME Study of [14C]-AZD1390

10. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

8

Phase

  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vereinigtes Königreich
      • Guildford, Vereinigtes Königreich, GU2 7WG
        • Research Site
      • Liverpool, Vereinigtes Königreich, L7 8XP
        • Research Site

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: AZD1390
Single dose of [14C]-AZD1390
Arzneimittel: AZD1390
single dose

Was misst die Studie?

Primäre Ergebnismessungen

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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
The phamrmacokinetic(s) of AZD1390 metabolite
Zeitfenster: 6 weeks
Analysis of plasma: Maximum observed concentration (Cmax)
6 weeks
The phamrmacokinetic(s) of AZD1390 metabolite
Zeitfenster: 6 weeks
Analysis of plasma: Area under the concentration-time curve from zero to infinity (AUCinf)
6 weeks
The phamrmacokinetic(s) of AZD1390 metabolite
Zeitfenster: 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
Zeitfenster: 6 weeks
Analysis of plasma: Time to reach maximum observed plasma concentration (Tmax)
6 weeks
The phamrmacokinetic(s) of AZD1390 metabolite
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 6 weeks
Analysis of metabolite in plasma: parent ratio
6 weeks
Metabolic profiling following single oral dose of AZD1390
Zeitfenster: 6 weeks
Quantification and identification of major metabolites of AZD1390 in plasma and excreta.
6 weeks
The safety of a single dose of AZD1390
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 6 weeks
Assessment of weight (measurement units can be variable) throughout the study.
6 weeks
The safety of a single dose of AZD1390
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

AstraZeneca

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

30. Juni 2026

Primärer Abschluss (Geschätzt)

12. April 2028

Studienabschluss (Geschätzt)

12. April 2028

Studienanmeldedaten

Zuerst eingereicht

18. Dezember 2025

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. Juni 2026

Zuerst gepostet (Tatsächlich)

12. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

12. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • D6940C00006

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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-Zeitrahmen

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-Zugriffskriterien

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.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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