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AstraZenecaA Phase I Study to Investigate the Pharmacokinetics and Safety of Capivasertib in Participants With Moderate Hepatic Impairment Fase I 20
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El ensayo clínico NCT07343960 está diseñado para estudiar la ciencia básica de Deterioro Hepático Moderado. Es un estudio intervencionista de Fase I. Su estado actual es: reclutando. El estudio se inició el 6 de enero de 2026, con el objetivo de reclutar a 20 participantes. Dirigido por AstraZeneca, se espera que finalice el 31 de julio de 2026. Los datos se actualizaron por última vez en ClinicalTrials.gov el 24 de febrero de 2026.
Resumen
The purpose of this study is to measure the pharmacokinetics (PK), safety, and tolerability of capivasertib in participants with moderate hepatic impairment and participants with normal hepatic function (as control).
Descripción detallada
This is a single dose, non-randomized, open-label, parallel group study. A Screening Period (Day -21 to -2): Participants in moderate impairment group will have an additional assessment of hepatic function stability on Day -7.
Treatment and Residential Period: Participants will be resident at the Investigative Site from Day -1 to Day 4 and will receive a single oral dose of capivasertib on Day 1.
Follow-up Period: ...
Mostrar másTítulo oficial
A Phase I, Single-dose, Non-randomized, Open-label, Parallel Group Study to Assess the Pharmacokinetics and Safety of Capivasertib in Participants With Moderate Hepatic Impairment
Condiciones médicas
Deterioro Hepático ModeradoOtros ID del estudio
- D3615C00004
Número del NCT
Inicio del estudio (real)
2026-01-06
Última actualización
2026-02-24
Fecha de finalización (estimada)
2026-07-31
Inscripción (prevista)
20
Tipo de estudio
Intervencionista
FASE
Fase I
Estado general
Reclutando
Palabras clave
Hepatic function
Anti-cancer agent
Pyrrolopyrimidine-derived compound
Liver metabolism
Serine/threonine protein kinase AKT
Pharmacokinetics
Anti-cancer agent
Pyrrolopyrimidine-derived compound
Liver metabolism
Serine/threonine protein kinase AKT
Pharmacokinetics
Objetivo principal
Ciencia básica
Método de asignación
No aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalTest: Capivasertib in Moderate hepatic impairment Participants with moderate hepatic impairment will receive a single dose of capivasertib. | Capivasertib Capivasertib will be administered orally |
ExperimentalControl: Capivasertib in Normal hepatic function Participants with normal hepatic function will receive a single dose of capivasertib. | Capivasertib Capivasertib will be administered orally |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Area under concentration time curve from zero to infinity (AUCinf) | To compare the PK (AUCinf) of a single oral dose of capivasertib in participants with moderate hepatic impairment to participants with normal hepatic function. | From Day 1 to Day 4 |
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) | To compare the PK (AUClast) of a single oral dose of capivasertib in participants with moderate hepatic impairment to participants with normal hepatic function. | From Day 1 to Day 4 |
Maximum plasma drug concentration (Cmax) | To compare the PK (Cmax) of a single oral dose of capivasertib in participants with moderate hepatic impairment to participants with normal hepatic function. | From Day 1 to Day 4 |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Concentration of capivasertib in plasma over time | To compare the plasma concentration of a single oral dose of capivasertib in participants with moderate hepatic impairment to participants with normal hepatic function. | From Day 1 to Day 4 |
Area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration (AUC0-t) | To compare the PK (AUC0-t) of a single oral dose of capivasertib in participants with moderate hepatic impairment to participants with normal hepatic function. | From Day 1 to Day 4 |
Time to Cmax (tmax) | To compare the PK (tmax) of a single oral dose of capivasertib in participants with moderate hepatic impairment to participants with normal hepatic function. | From Day 1 to Day 4 |
Terminal half-life (t½) | To compare the PK (t½) of a single oral dose of capivasertib in participants with moderate hepatic impairment to participants with normal hepatic function. | From Day 1 to Day 4 |
Apparent plasma clearance (CL/F) | To compare the PK (CL/F) of a single oral dose of capivasertib in participants with moderate hepatic impairment to participants with normal hepatic function. | From Day 1 to Day 4 |
Renal Clearance (CLR) | To compare the PK (CLR) of a single oral dose of capivasertib in participants with moderate hepatic impairment to participants with normal hepatic function. | From Day 1 to Day 3 |
Apparent volume of distribution (Vz/F) | To compare the PK (Vz/F) of a single oral dose of capivasertib in participants with moderate hepatic impairment to participants with normal hepatic function. | From Day 1 to Day 4 |
Number of participants with Adverse Events (AEs) and Serious AEs | To examine the safety and tolerability of a single oral dose of capivasertib in participants with moderate hepatic impairment and in those with normal hepatic function. | Up to Day 11 |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
Admisión de voluntarios sanos
Sí
- Body weight of at least 50 kg and Body Mass Index (BMI) of between ≥ 18 up to ≤ 40 kg/m2.
- Contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Participants must have suitable veins for cannulation or repeated venipuncture.
- Non-smoker, defined as a participant who has not smoked previously or who has discontinued smoking or the use of other nicotine/nicotine-containing products at least 3 months before the Screening Visit.
- Supporting documents confirming the participant's hepatic impairment must be available (a liver biopsy is preferable but not mandatory); participants must be classified by the Investigator as Child Pugh class B.
- Participants must meet National Cancer Institute - Organ Dysfunction Working Group (NCI-ODWG) classification of total bilirubin 1.5 to 3*upper limit of normal (ULN) and any Aspartate aminotransferase/transaminase (AST) for moderate hepatic impairment.
- Stable hepatic impairment
- For participants with normal hepatic function, Bilirubin < 1.5 × ULN, alanine aminotransferase (ALT), AST, albumin, alkaline phosphatase (ALP), gamma glutamyl transferase (GGT) < 1.2 × ULN. Creatinine < ULN. White blood cell count > lower limit of normal (LLN).
- Any evidence of diseases (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, significant aneurysm, renal transplant and active bleeding diseases) which makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.
- Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of capivasertib.
- History of primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include adequately resected non-melanoma skin cancer and curatively treated in situ disease.
- Active tuberculosis infection.
- Known Human Immunodeficiency Virus (HIV) infection, active hepatitis B or C infection, positive hepatitis C antibody, and/or positive hepatitis B virus surface antigen.
- Clinically significant abnormalities of glucose metabolism as defined by HemoglobinA1c (HbA1c) ≥ 8.0% (63.9 mmol/mol) at screening.
- Moderate or severe renal dysfunction according to age-related creatinine clearance estimated using CKD-EPI formula (i.e., creatinine clearance less than 60 mL/min).
- Fluctuating or rapidly deteriorating hepatic function.
- Presence of a hepatocellular carcinoma or acute liver disease caused by an infection or drug toxicity.
- Severe portal hypertension or surgical porto-systemic shunts.
- Biliary obstruction or other causes of hepatic impairment not related to parenchymal disorder and/or disease of the liver.
- Clinically relevant hepatic encephalopathy (Grade 3 or more).
- Severe ascites.
- Esophageal variceal bleeding (unless banded) within the past 2 months.
- Post-liver transplantation.
AstraZenecaParexelContactos centrales del estudio
Contacto: AstraZeneca Clinical Study Information Center, 1-877-240-9479, [email protected]
2 Centros del estudio en 1 países
California
Research Site, Rialto, California, 92377, United States
Reclutando
Texas
Research Site, San Antonio, Texas, 78215, United States
Reclutando