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

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Dextran sulfate

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Reference Values, Infusions, Intravenous, Intestinal Absorption, Dextran Sulfate, Administration, Oral, Blood Coagulation

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

Johns Hopkins Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00000690

First Posted

November 2, 1999

Last Updated

October 26, 2021

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

1. Study Identification

Unique Protocol Identification Number

NCT00000690

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

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Primary Completion Date

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Study Completion Date

October 1989 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Masking

None (Open Label)

Enrollment

6 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Dextran sulfate

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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.

Overall Study Officials: