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

Tracking Information

First Received Date ^ICMJE

November 2, 1999

Last Updated Date

June 23, 2005

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00000690 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Blood is withdrawn before the infusion, at the end of the infusion, and 30 and 60 minutes after the infusion.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

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Pharmacokinetics Study

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: Dextran sulfate

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Male

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00000690

Responsible Party

Study ID Numbers ^ICMJE

ACTG 078

Study Sponsor ^ICMJE

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:	P Lietman
Study Chair:	KJ Lorentsen
Study Chair:	CW Hendrix
Study Chair:	JM Collins
Study Chair:	DM Kornhauser
Study Chair:	BG Petty

Information Provided By

National Institute of Allergy and Infectious Diseases (NIAID)

Verification Date

June 1989

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP