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

• Status: Completed
• Trial end date: 1989-10-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Dextrans

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.