Status:

COMPLETED

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

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

HIV Infections

Eligibility:

MALE

18-40 years

Phase:

PHASE1

Brief 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 activit...

Detailed 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 hos...

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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

October 1 1989

Estimated Enrollment :

6 Patients enrolled

Trial Details

Trial ID

NCT00000690

End Date

October 1 1989

Last Update

November 2 2021

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Johns Hopkins Hosp

Baltimore, Maryland, United States, 21287