Single Dose Pharmacokinetics of Oral Dextran Sulfate (UA001) and Intravenous Dextran Sulfate in Healthy Volunteers
NCT ID: NCT00000690
Last Updated: 2021-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
6 participants
INTERVENTIONAL
1989-10-31
Brief Summary
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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.
Detailed Description
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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 Blood is withdrawn before the infusion, at the end of the infusion, and 30 and 60 minutes after the infusion.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.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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Dextran sulfate
Eligibility Criteria
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Exclusion Criteria
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.
18 Years
40 Years
MALE
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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P Lietman
Role: STUDY_CHAIR
KJ Lorentsen
Role: STUDY_CHAIR
CW Hendrix
Role: STUDY_CHAIR
JM Collins
Role: STUDY_CHAIR
DM Kornhauser
Role: STUDY_CHAIR
BG Petty
Role: STUDY_CHAIR
Locations
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Johns Hopkins Hosp
Baltimore, Maryland, United States
Countries
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References
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Flexner C, Barditch-Crovo PA, Kornhauser DM, Farzadegan H, Nerhood LJ, Chaisson RE, Bell KM, Lorentsen KJ, Hendrix CW, Petty BG, et al. Pharmacokinetics, toxicity, and activity of intravenous dextran sulfate in human immunodeficiency virus infection. Antimicrob Agents Chemother. 1991 Dec;35(12):2544-50. doi: 10.1128/AAC.35.12.2544.
Hiebert LM, Wice SM, Jaques LB, Williams KE, Conly JM. Orally administered dextran sulfate is absorbed in HIV-positive individuals. J Lab Clin Med. 1999 Feb;133(2):161-70. doi: 10.1016/s0022-2143(99)90009-4.
Lorentsen KJ, Hendrix CW, Collins JM, Kornhauser DM, Petty BG, Klecker RW, Flexner C, Eckel RH, Lietman PS. Dextran sulfate is poorly absorbed after oral administration. Ann Intern Med. 1989 Oct 1;111(7):561-6. doi: 10.7326/0003-4819-111-7-561.
Other Identifiers
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11053
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 078
Identifier Type: -
Identifier Source: org_study_id