Human ADME Study of [14C]-AZD1390

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат AZD1390
  single dose

Первичные конечные точки

• The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose [Срок оценки: 6 Weeks]
• The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose [Срок оценки: 6 Weeks]
• The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose [Срок оценки: 6 Weeks]
• The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose [Срок оценки: 6 Weeks]
• The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose [Срок оценки: 6 Weeks]
• The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose [Срок оценки: 6 Weeks]
• The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose [Срок оценки: 6 Weeks]
• The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose [Срок оценки: 6 Weeks]
• The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose [Срок оценки: 6 Weeks]
• The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose [Срок оценки: 6 Weeks]

Вторичные конечные точки (12)

• The phamrmacokinetic(s) of AZD1390 metabolite [Срок оценки: 6 weeks]
• The phamrmacokinetic(s) of AZD1390 metabolite [Срок оценки: 6 weeks]
• The phamrmacokinetic(s) of AZD1390 metabolite [Срок оценки: 6 weeks]
• The phamrmacokinetic(s) of AZD1390 metabolite [Срок оценки: 6 weeks]
• The phamrmacokinetic(s) of AZD1390 metabolite [Срок оценки: 6 weeks]
• The phamrmacokinetic(s) of AZD1390 metabolite [Срок оценки: 6 weeks]
• The phamrmacokinetic(s) of AZD1390 metabolite [Срок оценки: 6 weeks]
• The phamrmacokinetic(s) of AZD1390 metabolite [Срок оценки: 6 weeks]
• The phamrmacokinetic(s) of AZD1390 metabolite [Срок оценки: 6 weeks]
• Metabolic profiling following single oral dose of AZD1390 [Срок оценки: 6 weeks]
• The safety of a single dose of AZD1390 [Срок оценки: 6 weeks]
• The safety of a single dose of AZD1390 [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Великобритания · 2 центра

• Research Site — Guildford
• Research Site — Liverpool

Идентификаторы

NCT: NCT07643870 · D6940C00006

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗