Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000690
Status:
COMPLETED
Last Update Posted:
2021-11-02
First Post:
1999-11-02
Brief Title:
Single Dose Pharmacokinetics of Oral Dextran Sulfate UA001 and Intravenous Dextran Sulfate in Healthy Volunteers
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Single Dose Pharmacokinetics of Oral Dextran Sulfate UA001 and Intravenous Dextran Sulfate in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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needle sticks On 4th day each volunteer is given an injection of DS into vein 18 blood samples are obtained Blood is withdrawn before the infusion at the end of the infusion and 30 and 60 minutes after the infusion All urine is collected
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needle sticks On 4th day each volunteer is given an injection of DS into vein 18 blood samples are obtained Blood is withdrawn before the infusion at the end of the infusion and 30 and 60 minutes after the infusion All urine is collected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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11053 | REGISTRY | DAIDS ES Registry Number | None |