- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02217917
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Rivipansel With rHuPH20 in Healthy Subjects
16 de junio de 2020 actualizado por: GlycoMimetics Incorporated
A Phase 1, Randomized, Double Blind, Sponsor Open, Placebo Controlled, Single And Multiple Ascending Dose Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Rivipansel (pf 06460031) Following Subcutaneous Administration With Rhuph20 (pf 06744547) In Healthy Subjects
This is a 2 part study designed to provide an initial assessment on the safety, tolerability, and PK of rivipansel, following single ascending (Part 1) and multiple ascending dosing (Part 2) given subcutaneously with rHuPH20, in healthy subjects.
Part 1 of the study will be conducted using a cross-over design while Part 2 of the study will be conducted using a parallel design.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
27
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Brussels, Bélgica, B-1070
- Pfizer Clinical Research Unit
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 55 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive.
- Body Mass Index 17.5 - 30.5 kg/m2 and body weight >50 kg at Screening.
- Normal skin without potentially obscuring features in the area intended for infusion.
- Subjects willing to defer receiving prophylactic immunizations (eg, influenza or pneumococcal vaccines) during the study.
- Evidence of a personally signed and dated informed consent document indicating that the subject or a legally acceptable representative has been informed of all pertinent aspects of the study
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- History of a recent major surgery (within 3 months of screening).
- Serious infection within 1 month of screening.
- Subjects with chronic skin condition that may interfere in the assessment of emergent safety data.
- A positive urine drug screen.
- Known sensitivity to hyaluronidases.
- History of hepatitis or positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C antibodies (HCV).
- Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol.
- Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigator, or subjects who are Pfizer employees directly involved in the conduct of the study.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Cohort 1
Single ascending dose in 3 period cross-over design (with optional 4th period)
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Rivipansel administered as a single dose subcutaneously with rHuPH20 in cross-over fashion.
Each subject may receive up to 4 study treatments (placebo and up to 3 doses of rivipansel).
The planned dose levels are 350 mg, 1210 mg, and 4200 mg (these are subject to change based on emerging data).
Matched Placebo administered as single dose subcutaneously with rHuPH20.
Rivipansel administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20.
Planned doses are 1400 mg loading and 700 mg maintenance for 12 doses (these are subject to change based on emerging data).
Rivipansel administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20.
Planned doses are 2800 mg loading and 1400 mg maintenance for 12 doses (these are subject to change based on emerging data).
Matched Placebo administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20.
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Experimental: Cohort 2
Multiple ascending dose
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Rivipansel administered as a single dose subcutaneously with rHuPH20 in cross-over fashion.
Each subject may receive up to 4 study treatments (placebo and up to 3 doses of rivipansel).
The planned dose levels are 350 mg, 1210 mg, and 4200 mg (these are subject to change based on emerging data).
Matched Placebo administered as single dose subcutaneously with rHuPH20.
Rivipansel administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20.
Planned doses are 1400 mg loading and 700 mg maintenance for 12 doses (these are subject to change based on emerging data).
Rivipansel administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20.
Planned doses are 2800 mg loading and 1400 mg maintenance for 12 doses (these are subject to change based on emerging data).
Matched Placebo administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20.
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Experimental: Cohort 3
Multiple ascending dose
|
Rivipansel administered as a single dose subcutaneously with rHuPH20 in cross-over fashion.
Each subject may receive up to 4 study treatments (placebo and up to 3 doses of rivipansel).
The planned dose levels are 350 mg, 1210 mg, and 4200 mg (these are subject to change based on emerging data).
Matched Placebo administered as single dose subcutaneously with rHuPH20.
Rivipansel administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20.
Planned doses are 1400 mg loading and 700 mg maintenance for 12 doses (these are subject to change based on emerging data).
Rivipansel administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20.
Planned doses are 2800 mg loading and 1400 mg maintenance for 12 doses (these are subject to change based on emerging data).
Matched Placebo administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Assessment of adverse events (AEs)
Periodo de tiempo: Baseline up to 7 days of dosing
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Baseline up to 7 days of dosing
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Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG)
Periodo de tiempo: Baseline up to 7 days of dosing
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Baseline up to 7 days of dosing
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Assessment of vital signs (including blood pressure and pulse rate)
Periodo de tiempo: Baseline up to 7 days of dosing
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Baseline up to 7 days of dosing
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Assessment of clinical laboratory tests
Periodo de tiempo: Baseline up to 7 days of dosing
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Baseline up to 7 days of dosing
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Maximum Observed Plasma Concentration (Cmax) for rivipansel following single dose
Periodo de tiempo: Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration
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Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration
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Time to Reach Maximum Observed Plasma Concentration (Tmax) for rivipansel following single dose
Periodo de tiempo: Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration
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Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for rivipansel following single dose
Periodo de tiempo: Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration
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Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration
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Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for rivipansel following single dose
Periodo de tiempo: Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration
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Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration
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Dose-Normalized Cmax for rivipansel following single dose
Periodo de tiempo: Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration
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Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration
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Dose-Normalized AUClast for rivipansel
Periodo de tiempo: Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration
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Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration
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Dose-Normalized AUCinf for rivipansel
Periodo de tiempo: Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration
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Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration
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Plasma Decay Half-Life (t1/2) for rivipansel following single dose
Periodo de tiempo: Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration
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Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration
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Apparent Clearance (CL/F) for rivipansel following single dose
Periodo de tiempo: Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration
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Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration
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Apparent Volume of Distribution (Vz/F) for rivipansel following single dose
Periodo de tiempo: Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration
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Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration
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Maximum Observed Plasma Concentration (Cmax) for rivipansel following multiple dose
Periodo de tiempo: Days 1, 7
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Days 1, 7
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Time to Reach Maximum Observed Plasma Concentration (Tmax) for rivipansel following multiple dose
Periodo de tiempo: Days 1, 7
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Days 1, 7
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Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for rivipansel following multiple dose administration, where tau is 12 hours
Periodo de tiempo: Days 1, 7
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Days 1, 7
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Dose-Normalized Cmax for rivipansel following multiple dose administration
Periodo de tiempo: Days 1, 7
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Days 1, 7
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Dose-Normalized AUCtau for rivipansel following multiple dose administration
Periodo de tiempo: Days 1, 7
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Days 1, 7
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Plasma Decay Half-Life (t1/2) for rivipansel following multiple dose
Periodo de tiempo: Day 7
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Day 7
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Minimum Observed Plasma Concentration (Cmin) for rivipansel following multiple dose
Periodo de tiempo: Day 7
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Day 7
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Apparent Clearance (CL/F) for rivipansel following multiple dose
Periodo de tiempo: Day 7
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Day 7
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Peak to Trough Ratio (PTR) of plasma concentration for rivipanselmultiple dose administration
Periodo de tiempo: Day 7
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Day 7
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Accumulation ratio for Area Under the Curve during the dosing interval (Rac) for rivipansel
Periodo de tiempo: Day 7
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Day 7
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de octubre de 2015
Finalización primaria (Actual)
1 de abril de 2016
Finalización del estudio (Actual)
1 de abril de 2016
Fechas de registro del estudio
Enviado por primera vez
13 de agosto de 2014
Primero enviado que cumplió con los criterios de control de calidad
13 de agosto de 2014
Publicado por primera vez (Estimar)
15 de agosto de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de junio de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
16 de junio de 2020
Última verificación
1 de junio de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- B5201007
- 2014-002748-41 (Número EudraCT)
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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