Human ADME Study of [14C]-AZD1390
10 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
8
Phase
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: AstraZeneca Clinical Study Information Center
- Numéro de téléphone: 1-877-240-9479
- E-mail: information.center@astrazeneca.com
Lieux d'étude
-
-
-
Guildford, Royaume-Uni, GU2 7WG
- Research Site
-
Liverpool, Royaume-Uni, L7 8XP
- Research Site
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: AZD1390
Single dose of [14C]-AZD1390
|
single dose
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Délai: 6 Weeks
|
Amount excreted (Ae) (urine)
|
6 Weeks
|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Délai: 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
Délai: 6 Weeks
|
Amount excreted (Ae) (feaces)
|
6 Weeks
|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 6 weeks
|
Analysis of urine: Cumulative amount excreted (CumAe)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 after a single oral dose
Délai: 6 weeks
|
Analysis of urine: Fraction (percentage) excreted (Fe)
|
6 weeks
|
|
The distribution of total radioactivity into blood cells after a single oral dose
Délai: 6 weeks
|
Analysis of urine: Fraction (percentage) excreted (Fe)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 after a single oral dose
Délai: 6 weeks
|
Analysis of urine: Cumulative fraction (percentage) excreted (CumFe)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 after a single oral dose
Délai: 6 weeks
|
Analysis of urine: Renal clearance (CLR)
|
6 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The phamrmacokinetic(s) of AZD1390 metabolite
Délai: 6 weeks
|
Analysis of plasma: Maximum observed concentration (Cmax)
|
6 weeks
|
|
The phamrmacokinetic(s) of AZD1390 metabolite
Délai: 6 weeks
|
Analysis of plasma: Area under the concentration-time curve from zero to infinity (AUCinf)
|
6 weeks
|
|
The phamrmacokinetic(s) of AZD1390 metabolite
Délai: 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
Délai: 6 weeks
|
Analysis of plasma: Time to reach maximum observed plasma concentration (Tmax)
|
6 weeks
|
|
The phamrmacokinetic(s) of AZD1390 metabolite
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 6 weeks
|
Analysis of metabolite in plasma: parent ratio
|
6 weeks
|
|
Metabolic profiling following single oral dose of AZD1390
Délai: 6 weeks
|
Quantification and identification of major metabolites of AZD1390 in plasma and excreta.
|
6 weeks
|
|
The safety of a single dose of AZD1390
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 6 weeks
|
Assessment of weight (measurement units can be variable) throughout the study.
|
6 weeks
|
|
The safety of a single dose of AZD1390
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
30 juin 2026
Achèvement primaire (Estimé)
12 avril 2028
Achèvement de l'étude (Estimé)
12 avril 2028
Dates d'inscription aux études
Première soumission
18 décembre 2025
Première soumission répondant aux critères de contrôle qualité
10 juin 2026
Première publication (Réel)
12 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
12 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
10 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- D6940C00006
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime 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.
Délai de partage 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.
Critères d'accès au partage 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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .