Human ADME Study of [14C]-AZD1390
10 czerwca 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Jeszcze nie rekrutacja
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Szacowany)
8
Faza
- Faza 1
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: AstraZeneca Clinical Study Information Center
- Numer telefonu: 1-877-240-9479
- E-mail: information.center@astrazeneca.com
Lokalizacje studiów
-
-
-
Guildford, Zjednoczone Królestwo, GU2 7WG
- Research Site
-
Liverpool, Zjednoczone Królestwo, L7 8XP
- Research Site
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: AZD1390
Single dose of [14C]-AZD1390
|
single dose
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Ramy czasowe: 6 Weeks
|
Amount excreted (Ae) (urine)
|
6 Weeks
|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Ramy czasowe: 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
Ramy czasowe: 6 Weeks
|
Amount excreted (Ae) (feaces)
|
6 Weeks
|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 6 weeks
|
Analysis of urine: Cumulative amount excreted (CumAe)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 after a single oral dose
Ramy czasowe: 6 weeks
|
Analysis of urine: Fraction (percentage) excreted (Fe)
|
6 weeks
|
|
The distribution of total radioactivity into blood cells after a single oral dose
Ramy czasowe: 6 weeks
|
Analysis of urine: Fraction (percentage) excreted (Fe)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 after a single oral dose
Ramy czasowe: 6 weeks
|
Analysis of urine: Cumulative fraction (percentage) excreted (CumFe)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 after a single oral dose
Ramy czasowe: 6 weeks
|
Analysis of urine: Renal clearance (CLR)
|
6 weeks
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
The phamrmacokinetic(s) of AZD1390 metabolite
Ramy czasowe: 6 weeks
|
Analysis of plasma: Maximum observed concentration (Cmax)
|
6 weeks
|
|
The phamrmacokinetic(s) of AZD1390 metabolite
Ramy czasowe: 6 weeks
|
Analysis of plasma: Area under the concentration-time curve from zero to infinity (AUCinf)
|
6 weeks
|
|
The phamrmacokinetic(s) of AZD1390 metabolite
Ramy czasowe: 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
Ramy czasowe: 6 weeks
|
Analysis of plasma: Time to reach maximum observed plasma concentration (Tmax)
|
6 weeks
|
|
The phamrmacokinetic(s) of AZD1390 metabolite
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 6 weeks
|
Analysis of metabolite in plasma: parent ratio
|
6 weeks
|
|
Metabolic profiling following single oral dose of AZD1390
Ramy czasowe: 6 weeks
|
Quantification and identification of major metabolites of AZD1390 in plasma and excreta.
|
6 weeks
|
|
The safety of a single dose of AZD1390
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 6 weeks
|
Assessment of weight (measurement units can be variable) throughout the study.
|
6 weeks
|
|
The safety of a single dose of AZD1390
Ramy czasowe: 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
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
30 czerwca 2026
Zakończenie podstawowe (Szacowany)
12 kwietnia 2028
Ukończenie studiów (Szacowany)
12 kwietnia 2028
Daty rejestracji na studia
Pierwszy przesłany
18 grudnia 2025
Pierwszy przesłany, który spełnia kryteria kontroli jakości
10 czerwca 2026
Pierwszy wysłany (Rzeczywisty)
12 czerwca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
12 czerwca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
10 czerwca 2026
Ostatnia weryfikacja
1 czerwca 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- D6940C00006
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu IPD
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.
Ramy czasowe udostępniania IPD
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.
Kryteria dostępu do udostępniania IPD
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.
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Tak
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .