- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05019755
A Study to Investigate the Effect of Food on the Pharmacokinetics of IN-A002 Capsule in Healthy Male Subjects
A Randomized, Open-label, Single-dose, 2-way Crossover Clinical Trial to Investigate the Effect of Food on the Pharmacokinetics of IN-A002 Capsule in Healthy Male Subjects
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Sohyun Kim, BS
- Número de teléfono: +82-2-6477-0225
- Correo electrónico: sohyun.kim21@inno-n.com
Ubicaciones de estudio
-
-
-
Seoul, Corea, república de
- Reclutamiento
- Seoul National University Hospital, Dept. of Clinical Pharmacology
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Healthy male adults aged 19 to 55 years (inclusive) at the time of signing the informed consent form.
- Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m^2 with a body weight ≥ 50.0 kg and ≤ 90.0 kg at screening. BMI (kg/m^2) = Weight(kg) / {Height(m)}^2
- Decides to participate voluntarily in the study after being fully informed of and understanding the study completely, and provides his written informed consent prior to screening procedure.
- Determined eligible for this study in the opinion of the investigator based on the results of vital signs, physical examination, 12-lead electrocardiogram, clinical laboratory tests, and medical interview.
Exclusion Criteria:
- Has a history or current evidence of clinically significant disorder of hepatic, renal, nervous, respiratory, endocrine, hemato-oncologic, cardiovascular, urinary, and/or psychiatric system.
- Has a history or current evidence of gastrointestinal disease that may affect the safety and Pharmacokinetics assessment of investigational product(IP) or a history of gastrointestinal surgery (except for simple appendectomy or herniotomy).
- Has rheumatoid arthritis or has a history.
- Has symptomatic herpes simplex or herpes zoster or has a history within 3 months prior to the scheduled first dose.
- Has live vaccine dose within 3 months prior to the scheduled first dose or expects to receive live vaccine during the clinical trial period.
- Has a history or current evidence of clinically significant hypersensitivity to drugs containing any ingredient of Janus kinase inhibitor and other drugs.
- Has a positive result on serology tests (for hepatitis B, hepatitis C and human immunodeficiency virus [HIV], syphilis) during screening test.
- Has abnormalities one or more of the following during screening test: AST [GOT] or ALT [GPT] > 1.5 X upper limit of normal (ULN), Creatinine > upper limit of normal (ULN), ANC < 2,000/uL, Hb < 12.5 g/dL, Platelet < 150,000/uL, QTc interval at 12-lead electrocardiogram > 450 msec
- Systolic blood pressure (SBP) < 90 mmHg or > 140 mmHg, diastolic blood pressure (DBP) < 50 mmHg or > 95 mm Hg, or pulse rate (PR) < 45 beats/ min or > 100 beats/min on vital signs measured in sitting position after taking a rest for at least 5 minutes during screening test.
- Has a history of drug abuse or has a positive response to drug abuse on urine drug screening test.
- Has taken any prescription drugs or herbal medicine within 2 weeks prior to the expected date of first dose, or any over-the-counter (OTC) drug, health functional food or vitamin preparation within 1 week prior to the scheduled first dose (However, can participate in the study if otherwise eligible in the judgment of the investigator) or is expected to take such medication during the study.
- Has participated in any other clinical study, etc. and received IPs within 6 months prior to the scheduled first dose.
- Has donated whole blood within 2 months prior to the scheduled first dose, or has donated blood components or received transfusion within a month prior to the scheduled first dose.
- Has a history of excessive smoking (> 10 cigarettes/day) within 3 months prior to the scheduled first dose or confirmed as positive for cotinine on urine drug screening test.
- Excessive caffeine intake (> 5 units/day) or continued use of alcohol (> 21 units/week, 1 unit = 10 g of pure alcohol).
- Unable to stop drinking within 24 hrs prior to the scheduled first dose to post study visit.
- Unable to avoid caffeine-containing foods (e.g., coffee, tea [black tea, green tea, etc.], soda, coffee-flavored milk, and nutritive tonic drink, etc.) and foods containing grapefruit during each period from 24 hrs before hospitalization to discharge.
Unable to use a medically acceptable contraceptive method stated below and does not agree not to donate sperm from the scheduled first dose to 90 days after the last dose.
- Use of intrauterine device with a proven birth control failure rate by the spouse (or partner)
- Simultaneous use of (male or female) barrier method and spermicide
- Surgical sterilization of the subject or his partner (e.g., vasectomy, salpingectomy, tubal ligation, or hysterectomy)
- Determined ineligible for study participation by the investigator for other reasons.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: A(First period) to B(Second period) order
A: Oral Administration of IN-A002(IN-115314) in fasting status B: Oral Administration of IN-A002(IN-115314), 30 minutes after high-fat diet There will be a wash out period of 7days between period |
Oral Administration of IN-A002(IN-115314), single dose
|
Experimental: B(First period) to A(Second period) order
B: Oral Administration of IN-A002(IN-115314), 30 minutes after high-fat diet A: Oral Administration of IN-A002(IN-115314) in fasting status There will be a wash out period of 7days between period |
Oral Administration of IN-A002(IN-115314), single dose
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Cmax of IN-A002(IN-115314)
Periodo de tiempo: up to 72 hours
|
up to 72 hours
|
AUClast of IN-A002(IN-115314)
Periodo de tiempo: up to 72 hours
|
up to 72 hours
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
AUCinf of IN-A002(IN-115314)
Periodo de tiempo: up to 72 hours
|
up to 72 hours
|
Tmax of IN-A002(IN-115314)
Periodo de tiempo: up to 72 hours
|
up to 72 hours
|
t1/2 of IN-A002(IN-115314)
Periodo de tiempo: up to 72 hours
|
up to 72 hours
|
λz of IN-A002(IN-115314)
Periodo de tiempo: up to 72 hours
|
up to 72 hours
|
CL/F of IN-A002(IN-115314)
Periodo de tiempo: up to 72 hours
|
up to 72 hours
|
Vd/F of IN-A002(IN-115314)
Periodo de tiempo: up to 72 hours
|
up to 72 hours
|
Cmax of IN-116118(primary metabolite of IN-A002(IN-115314))
Periodo de tiempo: up to 72 hours
|
up to 72 hours
|
AUClast of IN-116118(primary metabolite of IN-A002(IN-115314))
Periodo de tiempo: up to 72 hours
|
up to 72 hours
|
AUCinf of IN-116118(primary metabolite of IN-A002(IN-115314))
Periodo de tiempo: up to 72 hours
|
up to 72 hours
|
Tmax of IN-116118(primary metabolite of IN-A002(IN-115314))
Periodo de tiempo: up to 72 hours
|
up to 72 hours
|
t1/2 of IN-116118(primary metabolite of IN-A002(IN-115314))
Periodo de tiempo: up to 72 hours
|
up to 72 hours
|
λz of IN-116118(primary metabolite of IN-A002(IN-115314))
Periodo de tiempo: up to 72 hours
|
up to 72 hours
|
Metabolite ratio of IN-116118(primary metabolite of IN-A002(IN-115314))
Periodo de tiempo: up to 72 hours
|
up to 72 hours
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
- IN_JSI_103
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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