A Study to Evaluate the Safety and Pharmacokinetics of Multiple Doses Upadacitinib, Tofacitinib, and Baricitinib in Healthy Adult Volunteers
A Phase 1 Open-label, Multiple Dose Study of Upadacitinib, Tofacitinib, and Baricitinib in Healthy Subjects to Evaluate Pharmacodynamic Biomarkers
This is a Phase 1, open label, five arm study to evaluate the pharmacodynamic effects of multiple doses of upadacitinib, tofacitinib, and baricitinib in healthy adult participants.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: ABBVIE CALL CENTER
- Número de teléfono: 844-663-3742
- Correo electrónico: abbvieclinicaltrials@abbvie.com
Ubicaciones de estudio
-
-
Illinois
-
Grayslake, Illinois, Estados Unidos, 60030
- Reclutamiento
- Acpru /Id# 286751
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Body Mass Index (BMI) is >= 18.0 to <= 32.0 kg/m2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
- A condition of general good health, based upon the results of a medical history, Physical Exam (PE), vital signs, laboratory profile and a 12-lead Electrocardiogram (ECG).
- A female must not be pregnant, or breastfeeding and is not considering becoming pregnant, cryopreserving her eggs or donating eggs during the study or for approximately 30 days after the last dose of study treatment.
Exclusion Criteria:
- History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, two or more prior episodes of herpes zoster, or one or more episodes of disseminated herpes zoster, one or more prior episodes of disseminated herpes simplex (including eczema herpeticum) or any uncontrolled medical illness.
- History of any clinically significant sensitivity or allergy to any medication or food.
- History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption [e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.].
- Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix.
- History or evidence of active tuberculosis (TB) disease or latent TB infection.
- Participant has prior exposure to upadacitinib, tofacitinib or baricitinib within the past 90 days.
- Participant requires any over-the-counter and/or prescription medication, vitamins, and/or herbal supplements on a regular basis.
- Participant has used any medications, vitamins and/or herbal supplements within the 2-week period prior to study treatment administration.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Arm 1: Multiple doses of Upadacitinib
Upadacitinib will be administered once daily |
Oral Tablet |
|
Experimental: Arm 2: Multiple doses of Tofacitinib
Tofacitinib will be administered twice daily |
Oral Tablet |
|
Experimental: Arm 3: Multiple doses of Upadacitinib
Upadacitinib will be administered once daily |
Oral Tablet |
|
Experimental: Arm 4: Multiple doses of Tofacitinib
Tofacitinib will be administered twice daily |
Oral Tablet |
|
Experimental: Arm 5: Multiple doses of Baricitinib
Baricitinib will be administered once daily |
Oral Tablet |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE)
Periodo de tiempo: Up to 44 Days
|
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events (TEAEs) are defined as any event that began or worsened in severity after the first dose of study drug. |
Up to 44 Days
|
|
Average plasma concentration (Cavg) of Upadacitinib
Periodo de tiempo: Up to 44 Days
|
Cavg of Upadacitinib |
Up to 44 Days
|
|
Average plasma concentration (Cavg) of Tofacitinib
Periodo de tiempo: Up to 44 Days
|
Cavg of Tofacitinib |
Up to 44 Days
|
|
Average plasma concentration (Cavg) of Baricitinib
Periodo de tiempo: Up to 44 Days
|
Cavg of Baricitinib |
Up to 44 Days
|
|
Area under the concentration-time curve over 24 hours (AUC24) of Upadacitinib
Periodo de tiempo: Up to 44 Days
|
AUC24 of Upadacitinib |
Up to 44 Days
|
|
Area under the concentration-time curve over 24 hours (AUC24) of Tofacitinib
Periodo de tiempo: Up to 44 Days
|
AUC24 of Tofacitinib |
Up to 44 Days
|
|
Area under the concentration-time curve over 24 hours (AUC24) of Baricitinib
Periodo de tiempo: Up to 44 Days
|
AUC24 of Baricitinib |
Up to 44 Days
|
|
Maximum Observed Plasma Concentration (Cmax) of Upadacitinib
Periodo de tiempo: Up to 44 Days
|
Cmax of Upadacitinib |
Up to 44 Days
|
|
Maximum Observed Plasma Concentration (Cmax) of Tofacitinib
Periodo de tiempo: Up to 44 Days
|
Cmax of Tofacitinib |
Up to 44 Days
|
|
Maximum Observed Plasma Concentration (Cmax) of Baricitinib
Periodo de tiempo: Up to 44 Days
|
Cmax of Baricitinib |
Up to 44 Days
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: ABBVIE INC., AbbVie
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- M26-625
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.
producto fabricado y exportado desde los EE. UU.
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