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Trial NCT00000690

Resource URI: http://static.linkedct.org/resource/trials/NCT00000690
PropertyValue
linkedct:brief_title Single Dose Pharmacokinetics of Oral Dextran Sulfate (UA001) and Intravenous Dextran Sulfate in Healthy Volunteers
linkedct:condition <http://static.linkedct.org/resource/condition/5486>
linkedct: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.
linkedct:description 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 Blood is withdrawn before the infusion, at the end of the infusion, and 30 and 60 minutes after the infusion.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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Male
linkedct:eligibility_healthy_volunteers Accepts Healthy Volunteers
linkedct:eligibility_maximum_age 40 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:enrollment 6 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000690
rdfs:label Trial NCT00000690
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:location <http://static.linkedct.org/resource/location/163631>
linkedct:nct_id NCT00000690
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Single Dose Pharmacokinetics of Oral Dextran Sulfate (UA001) and Intravenous Dextran Sulfate in Healthy Volunteers
linkedct:org_study_id ACTG 078
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/10798>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/14167>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/28007>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/33362>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/44868>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/5999>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000690>
linkedct:phase Phase 1
linkedct:reference <http://static.linkedct.org/resource/reference/1653>
linkedct:reference <http://static.linkedct.org/resource/reference/35500>
linkedct:reference <http://static.linkedct.org/resource/reference/39204>
linkedct:source National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:study_design Treatment, Open Label, Pharmacokinetics Study
linkedct:study_type Interventional
linkedct:summary To evaluate how the drug dextran sulfate (DS) is absorbed by the stomach and intestines when taken by mouth. To evaluate its effect on blood coagulation. 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.
rdf:type linkedct:trials
linkedct:verification_date June 1989