Single Dose Pharmacokinetics of Oral Dextran Sulfate (UA001) and Intravenous Dextran Sulfate in Healthy Volunteers
Data Collection
Blood-Borne Infections+15
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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 Blood is withdrawn before the infusion, at the end of the infusion, and 30 and 60 minutes after the infusion.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.6 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.From 18 to 40 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location