Search / Trial NCT00000690

Single Dose Pharmacokinetics of Oral Dextran Sulfate (UA001) and Intravenous Dextran Sulfate in Healthy Volunteers

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Trial Information

Current as of December 26, 2024

Completed

Keywords

Reference Values Infusions, Intravenous Intestinal Absorption Dextran Sulfate Administration, Oral Blood Coagulation

ClinConnect 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 Blood is withdrawn before the infusion, at the end of the infusion, and 30 and 60 minutes after the infusion.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.

Gender

MALE

Eligibility 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.

Trial Officials

P Lietman

Study Chair

KJ Lorentsen

Study Chair

CW Hendrix

Study Chair

JM Collins

Study Chair

DM Kornhauser

Study Chair

BG Petty

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Baltimore, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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