Study to Compare Bioavailability of GLPG1972 Given as 2 Different Tablet Formulations Versus an Oral Solution
Open-label Study to Compare the Bioavailability of an Oral Wet Granulation Tablet of GLPG1972 Relative to an Oral Solution and to an Oral Direct Compression Tablet After Single-dose Intake in Healthy Subjects, and to Evaluate the Effect of Food on the Bioavailability of an Oral Wet Granulation Tablet.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Inscripción (Actual)
Inscripción
Fase
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Antwerp, Bélgica
- SGS Belgium Life Sciences
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-
Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Male between 18 and 50 years of age, inclusive,
- A body mass index (BMI) between 18-30 kg/m², inclusive, weight of at least 50 kg.
- Judged by the investigator to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead ECG, and laboratory findings.
- Discontinuation of all medications except occasional paracetamol at least 2 weeks or 5 half-lives prior to the first study drug administration.
- Non-smokers and not using any nicotine-containing products.
- Negative urine drug screen and alcohol breath test.
- Current sexually active male agrees to use adequate contraception
- Willing to consume a non-vegetarian high-fat and high-calorie breakfast
- Able and willing to sign the ICF
Exclusion Criteria:
- Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug
- Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) or any history of hepatitis from any cause with the exception of hepatitis A.
- History of or a current immunosuppressive condition
- Symptoms of clinically significant illness in the 3 months before the initial study drug administration.
- History of malignancy within the past 5 years
- Clinically relevant abnormalities detected on ECG regarding either rhythm or conduction (e.g. QTcF >450 msec, or a known long QT syndrome).
- Presence of abnormal liver function
- Renal function with an estimated creatinine clearance <80 ml/min based on the Cockcroft-Gault formula.
- Presence of any condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
- Clinically relevant abnormalities detected on "vital signs"
- Dietary requirements precluding participation.
- Significant blood loss including blood donation or had a transfusion of any blood product within 12 weeks
- Hemoglobin level <7.5 mmol/L (12 g/dL).
- Active drug or alcohol abuse within 2 years prior to the initial study drug administration.
- Current (2 weeks before screening) and planned uninterrupted consumption of large quantities (> 6 cups) of coffee
- Administration of an injectable drug within 30 days prior to the initial study drug administration.
- Concurrent participation, or participation in a drug/device study within 8 weeks or 5 half-lives of the drug or within 6 months for biologicals
- Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
|
Experimental: Treatment A
GLPG1972 oral solution after overnight fast
|
Oral administration of GLPG1972 in four different treatment conditions (Treatments A throug D)
|
|
Experimental: Treatment B
GLPG1972 oral DC tablet after breakfast
|
Oral administration of GLPG1972 in four different treatment conditions (Treatments A throug D)
|
|
Experimental: Treatment C
GLPG1972 oral WG tablet after overnight fast
|
Oral administration of GLPG1972 in four different treatment conditions (Treatments A throug D)
|
|
Experimental: Treatment D
GLPG1972 oral WG tablet after breakfast
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Oral administration of GLPG1972 in four different treatment conditions (Treatments A throug D)
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Assessment of the maximum observed plasma concentration of GLPG1972 after single oral doses
Periodo de tiempo: on day 1 pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post doses
|
Determine bioavailability of GLPG1972 by assessing PK parameters
|
on day 1 pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post doses
|
|
Assessment of plasma concentration of GLPG1972 24hrs post-dose after single oral doses
Periodo de tiempo: At 24 hours post dose
|
Determine bioavailability of GLPG1972 by assessing PK parameters
|
At 24 hours post dose
|
|
Assessment of time to achieve the maximal plasma concentration of GLPG1972 after single oral doses
Periodo de tiempo: on day 1 pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post doses
|
Determine bioavailability of GLPG1972 by assessing PK parameters
|
on day 1 pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post doses
|
|
Assessment of the last quantifiable plasma concentration of GLPG1972 after single oral doses
Periodo de tiempo: on day 1 pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post doses
|
Determine bioavailability of GLPG1972 by assessing PK parameters
|
on day 1 pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post doses
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
the number of subjects with adverse events
Periodo de tiempo: at screening, pre-dose at date 1 and post-dose at 24 and 48 hours
|
To assess safety and tolerability of GLPG1972 given orally
|
at screening, pre-dose at date 1 and post-dose at 24 and 48 hours
|
|
the number of subjects with abnormal vital signs
Periodo de tiempo: at screening, pre-dose at date 1 and post-dose at 24 and 48 hours
|
To assess safety and tolerability of GLPG1972 given orally
|
at screening, pre-dose at date 1 and post-dose at 24 and 48 hours
|
|
the number of subjects with abnormal ECG
Periodo de tiempo: at screening, pre-dose at date 1 and post-dose at 24 and 48 hours
|
To assess safety and tolerability of GLPG1972 given orally
|
at screening, pre-dose at date 1 and post-dose at 24 and 48 hours
|
|
the number of subjects with abnormal laboratory assessments
Periodo de tiempo: at screening, pre-dose at date 1 and post-dose at 24 and 48 hours
|
To assess safety and tolerability of GLPG1972 given orally
|
at screening, pre-dose at date 1 and post-dose at 24 and 48 hours
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Director de estudio: Ann Fieuw, MD MSc, Galapagos NV
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Actual)
Finalización primaria
Finalización del estudio (Actual)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
Otros números de identificación del estudio
- GLPG1972-CL-105
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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