Single Dose Pharmacokinetics of Oral Dextran Sulfate (UA001) and Intravenous Dextran Sulfate in Healthy Volunteers
Colección de datos
Enfermedades Transmisibles+13
+ Enfermedades Urogenitales
+ Enfermedades Cardiovasculares
Estudio de Tratamiento
Resumen
DS has been reported to have anti-HIV activity. However, it is not known how much of the drug is absorbed into the bloodstream and can be used by the body when DS is taken by mouth. On 2nd day of hospitalization, each volunteer receives an oral dose of DS. Over the next 24 hours, 15 blood samples are obtained (from 15 separate needle sticks). On 4th day, each volunteer is given an injection of DS into vein. 18 blood samples are obtained. Blood is withdrawn before the infusion, at the end of the infusion, and 30 and 60 minutes after the infusion. All urine is collected.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 6 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Hombre
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 40 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Exclusion Criteria Co-existing Condition: Volunteers with any of the following are excluded: * Disorders of coagulation or disorders of plasma lipids. * Allergy to dextran sulfate, other sulfates, other dextrans. Concurrent Medication: Excluded: * Volunteers who anticipate need for medication during study. Volunteers with any of the following are excluded: * Disorders of coagulation or disorders of plasma lipids. * Allergy to dextran sulfate, other sulfates, other dextrans. Prior Medication: Excluded within 2 weeks of study entry: * Any medication. Risk Behavior: Excluded: * Ingestion of alcohol within 48 hours prior to study. * History of recent drug or alcohol abuse. * Disorders of coagulation or disorders of plasma lipids. * Allergy to dextran sulfate, other sulfates, other dextrans. Volunteers selected are: * In good general health as determined by screening history, physical examination, and laboratory panel within established limits of normal for hospital laboratory. * Consenting volunteers. * Available for 6 days of continuous hospitalization.
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación