- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07809789
Drug-Drug Interaction Study of Vorolanib Tablets in Healthy Participants
A Single-Center, Open-Label, Same-Subject Sequential Crossover Clinical Trial to Evaluate the Effects of Rifampicin or Itraconazole on the Pharmacokinetics of Vorolanib Tablets in Healthy Participants
This study adopts a single-center, open-label, same-subject sequential crossover clinical trial design, aiming to evaluate the effects of oral administration of rifampicin or itraconazole on the pharmacokinetic profiles of vorolanib tablets in healthy trial participants. The study consists of two treatment groups.
The rifampicin group is planned to enroll 18 healthy trial participants. Participants will receive a single oral dose of vorolanib tablets on the morning of Day 1, and continuous oral administration of rifampicin every morning from Day 6 to Day 17. On the morning of Day 15, participants will take vorolanib tablets and rifampicin.
The itraconazole group is planned to enroll 18 healthy trial participants to evaluate the effect of itraconazole on the pharmacokinetic profiles of vorolanib tablets. Participants will receive a single oral dose of vorolanib tablets on the morning of Day 1, and continuous oral administration of itraconazole every morning from Day 6 to Day 13. On the morning of Day 9, participants will take vorolanib tablets and itraconazole.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Zhejiang
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Hangzhou, Zhejiang, Porcelana, 310052
- Reclutamiento
- The Second Affiliated Hospital Zhejiang University School of Medicine
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Contacto:
- Bo Jiang
- Número de teléfono: 86-0571-87315215
- Correo electrónico: jiangbo@zju.ed
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- 1. Body weight: ≥45 kg for females and ≥50 kg for males; body mass index (BMI) at screening ranging from 19 to 26 kg/m² (inclusive) [BMI = weight (kg)/height² (m²)];
- 2. Results of examinations at screening and baseline (including physical examination, vital signs, laboratory tests: complete blood count, blood biochemistry, coagulation function, urinalysis, electrocardiogram, chest X-ray, etc.) are within normal limits, or abnormalities are present but judged by the investigator to have no clinical significance.
Exclusion Criteria:
- 1. History of chronic systemic or severe diseases involving the cardiovascular, hepatic, renal, pulmonary, gastrointestinal, neurological, musculoskeletal, hematopoietic or metabolic systems, particularly surgical conditions or illnesses that may affect drug absorption, distribution, metabolism and excretion;
- 2. A personal or family history of long QT syndrome, or QTcF interval >450 ms in males and >470 ms in females; clinically significant ventricular arrhythmias and conduction blocks;
- 3. Use of any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health supplements within 14 days prior to screening;
- 4. Special dietary requirements (habitual consumption of grapefruit juice or excessive tea, coffee and/or caffeine-containing beverages) and inability to abstain during the trial; inability to accept standardized meals during hospitalization;
- 5. Weekly alcohol intake of ≥14 alcohol units within 3 months before screening or positive breath alcohol test prior to enrolment; participants who cannot refrain from alcohol consumption throughout the study from signing the informed consent form until study completion.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: The rifampicin group
Participants will receive a single oral dose of vorolanib tablets on the morning of Day 1, and continuous oral administration of rifampicin every morning from Day 6 to Day 17.
On the morning of Day 15, participants will take vorolanib tablets and rifampicin.
|
Participants will receive a single oral dose of vorolanib tablets on the morning of Day 1, and continuous oral administration of rifampicin every morning from Day 6 to Day 17.
On the morning of Day 15, participants will take vorolanib tablets and rifampicin.
|
|
Experimental: The itraconazole group
Participants will receive a single oral dose of vorolanib tablets on the morning of Day 1, and continuous oral administration of itraconazole every morning from Day 6 to Day 13.
On the morning of Day 9, participants will take vorolanib tablets and itraconazole.
|
Participants will receive a single oral dose of vorolanib tablets on the morning of Day 1, and continuous oral administration of itraconazole every morning from Day 6 to Day 13.
On the morning of Day 9, participants will take vorolanib tablets and itraconazole.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Maximum plasma concentration (Cmax)
Periodo de tiempo: From pre-dose to 72 hours post-dose in rifampicin group. From pre-dose to 120 hours post-dose in itraconazole group.
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From pre-dose to 72 hours post-dose in rifampicin group. From pre-dose to 120 hours post-dose in itraconazole group.
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|
Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUC₀-t)
Periodo de tiempo: From pre-dose to 72 hours post-dose in rifampicin group. From pre-dose to 120 hours post-dose in itraconazole group.
|
From pre-dose to 72 hours post-dose in rifampicin group. From pre-dose to 120 hours post-dose in itraconazole group.
|
|
Area under the plasma concentration-time curve from time 0 to infinity (AUC₀-∞)
Periodo de tiempo: From pre-dose to 72 hours post-dose in rifampicin group. From pre-dose to 120 hours post-dose in itraconazole group.
|
From pre-dose to 72 hours post-dose in rifampicin group. From pre-dose to 120 hours post-dose in itraconazole group.
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CM082-CA-I-110
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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