Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00292942
Status:
COMPLETED
Last Update Posted:
2018-10-25
First Post:
2006-02-14
Brief Title:
Study of the Safety of Intravenous Artesunate
Sponsor:
US Army Medical Research and Development Command
Organization:
US Army Medical Research and Development Command
Study Overview
Official Title:
A Phase 1 Double-Blind Placebo-Controlled Randomized Multiple Dose Escalation Study to Evaluate the Safety Tolerance and PharmacokineticsPharmacodynamics of a New GMP Formulation of Intravenous Artesunate if Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2018-02
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:
The purpose of this study is to establish the safety tolerability and pharmacokinetics of a multiple dose of the antimalarial drug artesunate
Detailed Description:
This study was a Phase 1b randomized double-blind placebo-controlled trial using multiple ascending doses of intravenous artensunate AS to determine its safety tolerability and PK in healthy subjects Subjects were screened within 21 days of dosing At the screening visit subject underwent baseline assessments vital signs were recorded a physical examination urinalysis urine drug screen and urine pregnancy test were performed a complete blood cell count CBC with differential and indices reticulocyte count coagulation markers and blood chemistry assessments were performed and medical and medication history was collected Eligible subjects were scheduled for a 6-hour pre-dose electrocardiogram ECG and vital sign assessment with measurements taken at approx the same times as Day 1 dosing day On Day 0 subjects were admitted to the clinical pharmacology unit to begin the inpatient phase of the study Subjects had a brief physical examination and all procedures for the inpatient stay were reviewed On Day 1 pre-dose vital signs and ECG were performed Subjects then received study drug or placebo by IV bolus infusion Subjects were closely monitored by evaluating hemodynamic measurements periodic ECGs and assessment of spontaneously reported AEs Blood was drawn for blood count and chemistry analysis 6h and 24h after each dose PK blood samples were drawn pre-dose and approx 5min 20min 40min 1h 2h 4h 6h and 24h after each dose On Days 2 and 3 subjects received their second and third doses respectively of study drug or placebo with the same monitoring and laboratory measurements as for the first dose Subjects were discharged 24 hours after the 3rd dose of drug or placebo and were followed as outpatients on Days 7 10 and 15
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| USUHS G183SP | OTHER | None | None |
| A-13419 | OTHER | IRB | None |