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

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase: Completed; Phase 1

Conditions: HIV Infections

Treatments: Drug: Dextran sulfate

Study type: Interventional

Funder types: NIH

Identifiers

NCT00000690

ACTG 078

11053 (Registry Identifier)

Details and patient eligibility

About

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.

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 Blood is withdrawn before the infusion, at the end of the infusion, and 30 and 60 minutes after the infusion.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

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.