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- Ensayo clínico NCT02821858
Study to Investigate the Pharmacokinetics, Safety and Tolerability of Odalasvir and AL-335 in Healthy Japanese Participants
28 de marzo de 2018 actualizado por: Janssen Research & Development, LLC
A Phase 1, Double-blind, Placebo-controlled, Randomized, Single Ascending Dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of Odalasvir and AL-335 in Healthy Japanese Subjects
The purpose of this study is to investigate the pharmacokinetics (PK), safety and tolerability following single oral administration of ascending doses of odalasvir (ODV) in healthy Japanese participants (Panel 1) and to investigate the PK, safety and tolerability following single oral administration of ascending doses of AL-335 in healthy Japanese participants (Panel 2; Sequential Design).
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
40
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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Surrey, Reino Unido
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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
20 años a 55 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Participant must be a Japanese participant who has resided outside Japan for no more than 5 years and whose parents and grandparents are Japanese as determined by participant's verbal report
- Participant must have a body mass index (BMI: weight in kilogram [kg] divided by the square of height in meters) of 18.0 to 30.0 kilogram per meter square (kg/m^2), extremes included and a body weight not less than 50.0 kilogram (kg)
- Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at Screening. If there are abnormalities, the participant may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the Investigator
- Participant must have a blood pressure (after the participant supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted
- Female participant must agree to not donate eggs (ova, oocytes) for the purpose of assisted reproduction during the study and for a period of 60 days (Panel 1) or 30 days (Panel 2) after study drug administration or until the last follow-up visit, whichever occurs later
Exclusion Criteria:
- Participant has a history of liver or renal insufficiency (estimated creatinine clearance below 80 milliliters per minute [mL/min]); significant cardiac, vascular, pulmonary, gastrointestinal (such as significant diarrhea, gastric stasis, or constipation that in the Investigator's opinion could influence drug absorption or bioavailability), endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic or metabolic disturbances
- Participant has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
- Participant with a past history of heart arrhythmias (for example, extra systolic beats or tachycardia at rest); risk factors associated with Torsade de Pointes such as hypokalemia or family history of short/long QT syndrome or sudden unexplained death (including sudden infant death syndrome) in a first-degree relative [for example, sibling, offspring, or biological parent])
- Participant with any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria
- Participant has known allergies, hypersensitivity, or intolerance to odalasvir (ODV) or AL-335 or its excipients
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: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Panel 1: Treatment A
Participants will receive odalasvir (ODV) 50 milligram (mg) (n=8) or placebo (n=2) on Day 1.
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Se administrará el placebo correspondiente.
ODV 50 mg (1 tablet) in Treatment A, 100 mg (2 tablets of 50 mg) in Treatment B and 300 mg (6 tablets of 50 mg) in Treatment C.
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Experimental: Panel 1: Treatment B
Participants will receive ODV 100 mg (n=8) or placebo (n=2) on Day 1.
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Se administrará el placebo correspondiente.
ODV 50 mg (1 tablet) in Treatment A, 100 mg (2 tablets of 50 mg) in Treatment B and 300 mg (6 tablets of 50 mg) in Treatment C.
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Experimental: Panel 1: Treatment C
Participants will receive ODV 300 mg (n=8) or placebo (n=2) on Day 1.
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Se administrará el placebo correspondiente.
ODV 50 mg (1 tablet) in Treatment A, 100 mg (2 tablets of 50 mg) in Treatment B and 300 mg (6 tablets of 50 mg) in Treatment C.
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Experimental: Panel 2: Treatment D
Participants will receive AL-335 400 mg (n=8) or placebo (n=2) on Day 1 of Period 1.
Each treatment period will be separated by a washout period of 7 days.
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Se administrará el placebo correspondiente.
AL-335 400 mg (1 tablet) in Treatment D, 800 mg (2 tablets of 400 mg) in Treatment E and 1200 mg (3 tablets of 400 mg) in Treatment F.
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Experimental: Panel 2: Treatment E
Participants will receive AL-335 800 mg (n=8) or placebo (n=2) on Day 1 of Period 2. Each treatment period will be separated by a washout period of 7 days.
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Se administrará el placebo correspondiente.
AL-335 400 mg (1 tablet) in Treatment D, 800 mg (2 tablets of 400 mg) in Treatment E and 1200 mg (3 tablets of 400 mg) in Treatment F.
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Experimental: Panel 2: Treatment F
Participants will receive AL-335 1,200 mg (n=8) or placebo (n=2) on Day 1 of Period 3.
Each treatment period will be separated by a washout period of 7 days.
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Se administrará el placebo correspondiente.
AL-335 400 mg (1 tablet) in Treatment D, 800 mg (2 tablets of 400 mg) in Treatment E and 1200 mg (3 tablets of 400 mg) in Treatment F.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Maximum Observed Concentration (Cmax) of Odalasvir (ODV)
Periodo de tiempo: From Day 1 to Day 14 after intake of ODV
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The Cmax is the maximum observed analyte concentration.
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From Day 1 to Day 14 after intake of ODV
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Time to Reach Maximum Observed Concentration (Tmax) of ODV
Periodo de tiempo: From Day 1 to Day 14 after intake of ODV
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The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
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From Day 1 to Day 14 after intake of ODV
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Area Under the Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of ODV
Periodo de tiempo: From Day 1 to Day 50-55 after intake of ODV
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The (AUC [0-last]) is the area under the analyte concentration-time curve from time 0 to time of the last quantifiable concentration.
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From Day 1 to Day 50-55 after intake of ODV
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Elimination Rate Constant (Lambda[z]) of ODV
Periodo de tiempo: From Day 1 to Day 50-55 after intake of ODV
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Lambda(z) is first order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
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From Day 1 to Day 50-55 after intake of ODV
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Elimination Half-Life (t1/2) of ODV
Periodo de tiempo: From Day 1 to Day 50-55 after intake of ODV
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Elimination half-life (t[1/2]) is associated with the terminal slope (lambda [z]) of the semi-logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).
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From Day 1 to Day 50-55 after intake of ODV
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Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of ODV
Periodo de tiempo: From Day 1 to Day 50-55 after intake of ODV
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The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
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From Day 1 to Day 50-55 after intake of ODV
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Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability for ODV
Periodo de tiempo: Up to 50-55 days after intake of ODV
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Up to 50-55 days after intake of ODV
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Maximum Observed Concentration (Cmax) of AL-335
Periodo de tiempo: From Day 1 to Day 4 after intake of AL-335
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The Cmax is the maximum observed analyte concentration.
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From Day 1 to Day 4 after intake of AL-335
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Time to Reach Maximum Observed Concentration (Tmax) of AL-335
Periodo de tiempo: From Day 1 to Day 4 after intake of AL-335
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The Tmax is defined as actual sampling time to reach maximum observed concentration.
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From Day 1 to Day 4 after intake of AL-335
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Area Under the Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of AL-335
Periodo de tiempo: From Day 1 to Day 4 after intake of AL-335
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The (AUC [0-last]) is the area under the concentration-time curve from time 0 to time of the last quantifiable concentration.
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From Day 1 to Day 4 after intake of AL-335
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Elimination Rate Constant (Lambda[z]) of AL-335
Periodo de tiempo: From Day 1 to Day 4 after intake of AL-335
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Lambda(z) is first order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
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From Day 1 to Day 4 after intake of AL-335
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Elimination Half-Life (t1/2) of AL-335
Periodo de tiempo: From Day 1 to Day 4 after intake of AL-335
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Elimination half-life (t[1/2]) is associated with the terminal slope (lambda [z]) of the semi-logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).
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From Day 1 to Day 4 after intake of AL-335
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Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of AL-335
Periodo de tiempo: From Day 1 to Day 4 after intake of AL-335
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The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
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From Day 1 to Day 4 after intake of AL-335
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Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability for AL-335
Periodo de tiempo: Up to 30 to 35 days after last intake of AL-335
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Up to 30 to 35 days after last intake of AL-335
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Janssen Research and Developement, LLC Clinical Trial, Janssen Research and Developement, LLC
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 (Actual)
14 de junio de 2016
Finalización primaria (Actual)
9 de septiembre de 2016
Finalización del estudio (Actual)
30 de septiembre de 2016
Fechas de registro del estudio
Enviado por primera vez
10 de junio de 2016
Primero enviado que cumplió con los criterios de control de calidad
29 de junio de 2016
Publicado por primera vez (Estimar)
4 de julio de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
29 de marzo de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
28 de marzo de 2018
Última verificación
1 de marzo de 2018
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CR108178
- 64294178HPC1005 (Otro identificador: Janssen Research & Development, LLC)
- 2015-005639-42 (Número EudraCT)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
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