Single Dose Pharmacokinetics of Oral Dextran Sulfate (UA001) and Intravenous Dextran Sulfate in Healthy Volunteers
Collecte de données
Infections transmises par le sang+15
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
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 Blood is withdrawn before the infusion, at the end of the infusion, and 30 and 60 minutes after the infusion.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.6 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Homme
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 40 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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.
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site