- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02731885
Food Effect on Pharmacokinetic Parameters of ABX464
An Open, Randomized Study, to Investigate the Potential Food Effect on Pharmacokinetic Parameters of ABX464 Administered Orally to Healthy Male Subjects
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a phase I, single-center, open-label, two-treatment, food-effect, randomized study in 40 healthy Caucasian male subjects in order to determine the impact of the food on the absorption of the ABX464.
The two different treatments are the followings:
- Treatment A = 50mg of ABX464 (two 25mg capsules) /Fasted
- Treatment B = 50mg of ABX464 (two 25mg capsules) / Fed
This study consists of two groups:
- Group 1 - single dose assessments, two-period, two-treatment, cross-over: 20 subjects will receive a single dose of 50mg of ABX464 in fed and fasted condition, separated by a wash-out period of at least 45 days.
- Group 2 - multiple dose assessments: 20 subjects will receive 50mg of ABX464 every 3 days during 10 days in fasted or fed condition.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Phoenix
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Sayed Hossen road, Phoenix, Mauricio
- CAP Research
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Healthy Caucasian male subjects, 18-55 years of age
- Body Mass Index (BMI) of 17-28 kg/m².
- Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination)
Normal vital signs after 10 minutes resting in supine position:
90 mmHg < systolic blood pressure < 140 mmHg, 50 mmHg < diastolic blood pressure < 90 mmHg, 40 bpm < heart rate < 100 bpm.
- Normal automatic 12-lead ECG (incomplete right bundle branch block can be accepted) or judged as non clinically significant.
- Clinical laboratory tests (hematology, blood chemistry, and urinalysis) must be within normal limits or clinically acceptable to Investigator and Sponsor.
- Subjects must be willing to give written informed consent prior to study enrollment and be able to adhere to restrictions and examination schedules.
Exclusion Criteria:
- Individuals with a history of any significant medical disorder which requires a physician's care (cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic, or infectious disease; any acute infectious disease or signs of acute illness)
- Frequent headaches and / or migraine, recurrent nausea and / or vomiting (more than twice a month).
- Presence or history of drug allergy, or allergic disease diagnosed and treated by a physician.
- Individuals who have a history of any clinically significant local or systemic infectious disease within 4 weeks prior to drug administration.
- Any individual who does not comply with the requirement that he should not have used any drugs other than paracetamol for at least 2 weeks prior to the study nor alcohol within 48 hours prior to drug administration.
- Individuals who are positive for hepatitis B virus, hepatitis C virus or HIV.
- History or presence of drug or alcohol abuse (positive urine drug screen, positive alcohol breath test).
- Smoking more than 5 cigarettes or equivalent / day, unable to stop smoking during the study.
- Excessive consumption of beverages with xanthine bases (> 4 cups or glasses / day).
- Subject who will likely be unable to eat entirely the standard high fat breakfast within the allocated time.
- Individuals who have donated blood within the preceding 3 months.
- Individuals who refuse to use an effective method of contraception from the beginning of the study and until 3 months after dosing.
- Individuals with forfeiture of freedom by an administrative or legal obligation or under guardianship
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: Fasted Conditions
50mg of ABX464 (two 25mg capsules) /Fasted
|
Two-periods, subjects received a single dose of 50mg of ABX464 in fed and fasted condition, separated by a wash-out period of at least 45 days.
Subjects received 50mg of ABX464 every 3 days during 10 days in fasted or fed condition.
|
|
Experimental: Fed Conditions
50mg of ABX464 (two 25mg capsules) /Fed
|
Two-periods, subjects received a single dose of 50mg of ABX464 in fed and fasted condition, separated by a wash-out period of at least 45 days.
Subjects received 50mg of ABX464 every 3 days during 10 days in fasted or fed condition.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Area under the plasma concentration versus time curve (AUC) of single oral dose of 50mg of ABX464 in fed or fasted condition.
Periodo de tiempo: 45 days
|
45 days
|
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Peak Plasma Concentration (Cmax) of single oral dose of 50mg of ABX464 in fed or fasted condition.
Periodo de tiempo: 45 days
|
45 days
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Area under the plasma concentration versus time curve (AUC) of repeated doses of 50 mg of ABX464 in fed or fasted conditions
Periodo de tiempo: 10 days
|
10 days
|
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Peak Plasma Concentration (Cmax) of repeated doses of 50 mg of ABX464 in fed or fasted conditions
Periodo de tiempo: 10 days
|
10 days
|
|
Number of Subjects with treatment-related adverse events as assessed by CTCAE v4.0
Periodo de tiempo: Up to 45 days
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Up to 45 days
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- ABX464-FE-001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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