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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000690
First Posted: August 31, 2001
Last Update Posted: March 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
November 2, 1999
August 31, 2001
March 17, 2014
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Complete list of historical versions of study NCT00000690 on ClinicalTrials.gov Archive Site
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Single Dose Pharmacokinetics of Oral Dextran Sulfate (UA001) and Intravenous Dextran Sulfate in Healthy Volunteers
Single Dose Pharmacokinetics of Oral Dextran Sulfate (UA001) and Intravenous Dextran Sulfate in Healthy Volunteers

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.

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 Blood is withdrawn before the infusion, at the end of the infusion, and 30 and 60 minutes after the infusion.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

Interventional
Phase 1
Masking: None (Open Label)
Primary Purpose: Treatment
HIV Infections
Drug: Dextran sulfate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
October 1989
Not Provided

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.
Sexes Eligible for Study: Male
18 Years to 40 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00000690
ACTG 078
11053 ( Registry Identifier: DAIDS ES Registry Number )
Not Provided
Not Provided
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Study Chair: P Lietman
Study Chair: KJ Lorentsen
Study Chair: CW Hendrix
Study Chair: JM Collins
Study Chair: DM Kornhauser
Study Chair: BG Petty
National Institute of Allergy and Infectious Diseases (NIAID)
March 2012

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