- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02071004
DS1040b/Aspirin Drug/Drug Interaction Study
20 de diciembre de 2018 actualizado por: Daiichi Sankyo, Inc.
A PHASE 1, OPEN LABEL, SINGLE DOSE STUDY, TO ASSESS THE SAFETY AND TOLERABILITY OF A SINGLE IV DOSE OF DS-1040B AFTER 5 DAYS OF ASPIRIN TREATMENT IN HEALTHY SUBJECTS
This is a phase 1, open label, single dose study, after 5 days of aspirin treatment, in healthy male and female subjects.
It is hypothesized that co-administering DS-1040b with aspirin at steady state will be safe and well tolerated by healthy male and female subjects.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
18
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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London, Reino Unido, NW10 7EW
- Hammersmith Medicines Research Ltd.
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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 45 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Healthy male and female subjects, aged 18 to 45 years.
- A body mass index (BMI, or Quetlet index) in the range of 18.0 to 30.0 kg/m2, and weighing between 50 and 100 kg at screening.
- Male subjects have to agree to contraception (condom with spermicide) in addition to having their female partner (if of child-bearing potential) use another form of contraception (e.g., an intrauterine device, diaphragm with spermicide, oral contraceptive, injectable, or sub dermal hormonal implant) from the first dose until 16 weeks following the last dose administration. Also, the male subjects must not donate sperm after the study for a period of four months.
- All women must have a negative serum pregnancy test at screening and a negative urine pregnancy test at admission (Day -1). Women must be of non-childbearing potential either: Surgically sterile (i.e., bilateral tubal ligation or removal of both ovaries and/or uterus at least 6 months prior to dosing) or naturally postmenopausal (spontaneous cessation of menses) for at least 24 consecutive months prior to dosing, with a follicle stimulating hormone (FSH) level at screening of ≥ 40 mIU/mL.
- Sufficient intelligence to understand the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the Investigator and to participate in, and comply with the requirements of, the entire trial.
- Willingness to give written consent to participate after reading the ICF, and after having the opportunity to discuss the trial with the Investigator or his delegate.
- Willingness to give written consent to have data entered into The Overvolunteering Prevention Scheme.
- Willing to abstain from grapefruit/grapefruit juice and Seville oranges from 7 days before the first dose and throughout the study.
- Willing to refrain from consuming food or beverages containing caffeine/xanthine starting 24 hours prior to check-in on Day -1.
Exclusion Criteria:
- Clinically relevant abnormal history, including cardiovascular, haematologic, pulmonary, hepatic, renal, gastrointestinal, connective tissue disease, uncontrolled endocrine/metabolic, oncologic (within the last 5 years), neurologic (including previous transient ischemic attack or stroke), and psychiatric diseases, physical findings, ECG, or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the volunteer.
- History of a serious reaction to any medicine.
- History of major bleeding, stomach ulcer, Raynaud's disease, major trauma, or major surgical procedure of any type within 6 months of dosing.
- History of minor bleeding episodes such as epistaxis, rectal bleeding (spots of blood on toilet paper), and gingival bleeding within 3 months before the study treatment.
- Familial or documented or suspected coagulopathy and haemoglobinopathy.
- Females with a history of dysfunctional uterine bleeding, including history of menorrhagia, metrorrhagia, or polymenorrhea.
- History of an operation (e.g. stomach bypass), or a condition that could affect how the body handles or absorbs medicines.
- History of gastro-oesophageal reflux disease.
- Females who are breastfeeding.
- Positive urine or faecal occult blood test at screening or admission (Day -1 or day 1).
- Bleeding time > 9.5 minutes at screening).
- aPTT, PT, INR, or platelet count outside the limit of normal of the clinical laboratory's reference range at screening.
- Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2 (based on Modification of Diet in Renal Disease [MDRD] equation).
- Positive test for hepatitis B, hepatitis C, HIV1 & HIV2.
- QTcF interval duration > 430 msec for males and 450 msec for females, obtained as an average from the 3 ECG measurements on the triplicate screening ECGs.
- Abnormal waveform morphology on any of the ECGs at screening at admission that would preclude accurate measurement of the QT interval duration.
- Physical trauma, dental extraction, surgery, or a significant illness within 4 weeks before the first dose.
- History or presence of keloid, hyperpigmentation, or other adverse reaction to skin injury or surgery.
- Use of any prescribed or non-prescribed (over-the-counter [OTC]) systemic medications (including anticoagulants or antiplatelet medications), topical medications, or herbal supplements within 14 days before the first dose (excluding paracetamol ≤ 2 g/day). St. John's Wort (hypericin) must not have been taken for at least 30 days before the first dose.
- Donated or lost > 400 mL of blood or plasma during 3 months before the first dose on Day 1.
- Donation of blood, plasma, platelets, or any other blood components during the 3 months before the trial, or unwilling to abstain from doing so during the study and for 3 months after receipt of trial medication.
- Participated in a clinical study involving administration of an investigational drug, or a marketed drug within 90 days before administration of the first dose.
- Male subjects who consume more than 21 units of alcohol per week or female subjects who consume more than 14 units of alcohol per week (1 unit of alcohol equals 1/2 pint of beer, a glass of wine, or 1 measure of spirits) or those subjects who have a significant history of alcoholism or drug/chemical abuse within the last 2 years.
- Use of tobacco products or nicotine-containing products within 3 months before the first dose.
- Positive results on tests for drugs of abuse, carbon monoxide, or alcohol at screening or admission.
- Possibility that the volunteer will not cooperate with the requirements of the protocol.
- Objection by General Practitioner (GP) to volunteer entering the trial.
- Known aspirin allergy or intolerance.
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: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Otro: Aspirin
Dispersible tablet, 300mg & 75 mg, once daily for 5 days
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Dispersible tablet, 300mg & 75 mg, once daily for 5 days
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Experimental: DS-1040b
IV of 6 mg given once over 30 minutes
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IV of 6 mg given once over 30 minutes
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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bleeding time
Periodo de tiempo: day 0 to day 5 after dosing
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To assess the safety (including bleeding time) and tolerability of a single IV dose of DS-1040b following 5 days aspirin treatment in healthy subjects
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day 0 to day 5 after dosing
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
change in D-dimer level
Periodo de tiempo: day 0 - day 5 after dosing
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To assess the effect of a single IV dose of DS-1040b following 5 days aspirin treatment on D-dimer levels
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day 0 - day 5 after dosing
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Cmax
Periodo de tiempo: Days 5, 6, and 7 after dosing
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Plasma concentration time data of DS-1040a (the free form of DS-1040b) will be analyzed using non-compartmental methods. The following parameters will be estimated and reported: . |
Days 5, 6, and 7 after dosing
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Tmax
Periodo de tiempo: Days 5, 6, and 7 after dosing
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Plasma concentration time data of DS-1040a (the free form of DS-1040b) will be analyzed using non-compartmental methods.
The following parameters will be estimated and reported:
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Days 5, 6, and 7 after dosing
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AUC
Periodo de tiempo: Days 5, 6, and 7 after dosing
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Plasma concentration time data of DS-1040a (the free form of DS-1040b) will be analyzed using non-compartmental methods.
The following parameters will be estimated and reported:
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Days 5, 6, and 7 after dosing
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half-life
Periodo de tiempo: Days 5, 6, and 7 after dosing
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Plasma concentration time data of DS-1040a (the free form of DS-1040b) will be analyzed using non-compartmental methods.
The following parameters will be estimated and reported:
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Days 5, 6, and 7 after dosing
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
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 enero de 2014
Finalización primaria (Actual)
1 de febrero de 2014
Finalización del estudio (Actual)
1 de febrero de 2014
Fechas de registro del estudio
Enviado por primera vez
21 de febrero de 2014
Primero enviado que cumplió con los criterios de control de calidad
24 de febrero de 2014
Publicado por primera vez (Estimar)
25 de febrero de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de diciembre de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
20 de diciembre de 2018
Última verificación
1 de febrero de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Carrera
- Accidente cerebrovascular isquémico
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes del sistema nervioso periférico
- Inhibidores de enzimas
- Analgésicos
- Agentes del sistema sensorial
- Agentes antiinflamatorios no esteroideos
- Analgésicos no narcóticos
- Agentes antiinflamatorios
- Agentes antirreumáticos
- Agentes fibrinolíticos
- Agentes moduladores de fibrina
- Inhibidores de la agregación plaquetaria
- Inhibidores de la ciclooxigenasa
- Antipiréticos
- Aspirina
Otros números de identificación del estudio
- DS1040-A-E102
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Sí
Descripción del plan IPD
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/.
In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants.
Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Marco de tiempo para compartir IPD
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Criterios de acceso compartido de IPD
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research.
This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Tipo de información de apoyo para compartir IPD
- Protocolo de estudio
- Plan de Análisis Estadístico (SAP)
- Formulario de consentimiento informado (ICF)
- Informe de estudio clínico (CSR)
- Código analítico
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. .
Ensayos clínicos sobre Aspirin
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Seoul National University HospitalCKD Pharmaceutical LimitedTerminado
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Xuanwu Hospital, BeijingTerminadoAccidente cerebrovascular isquémico agudo