At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 26 enrolled

Drug / intervention

Intravenous Artesunate +1 moredrug

Likely dose

Intravenous artesunate 2, 4, or 8 mg/kgAI-extracted

Key inclusion· 5

✓Healthy adult males and non-pregnant, non-lactating females
✓Normal ECG that may include benign PACs and PVCs, 1st degree AV block, 2nd degree AV block (Wenckebach)
✓Normal blood pressure (systolic <140 mm Hg, diastolic <90 mm Hg) and heart rate (50–90 bpm without symptoms)
✓BMI between 18 and 29 kg/m² or not clinically significant (within 15% of ideal body weight)

Key exclusion· 16

✕Any investigational drug or vaccine within 16 weeks before entry
✕Liquid protein diet within the past year
✕Prescription drugs within 14 days or non-prescription drugs/herbals/supplements within 7 days prior to admission
✕Surgical or medical condition that might interfere with drug distribution, metabolism, or excretion

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00292942

NCT00292942Phase 1Completed

Compare CT.gov

A Phase 1 Double-Blind, Placebo-Controlled, Randomized Multiple Dose Escalation Study to Evaluate the Safety, Tolerance, and Pharmacokinetics/Pharmacodynamics of a New GMP Formulation of Intravenous Artesunate if Healthy Subjects

U.S. Army Medical Research and Development Command·interventional·Posted Feb 16, 2006·Updated Oct 25, 2018

In Brief

A Phase 1 clinical trial evaluating Intravenous Artesunate and Placebo for Malaria and Malaria, Cerebral. Completed, enrolled 26 participants across 1 site.

Detailed Summary

The purpose of this study is to establish the safety, tolerability, and pharmacokinetics of a multiple dose of the antimalarial drug artesunate.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsMalaria, Malaria, Cerebral

CountriesUnited States

CollaboratorsWalter Reed Army Institute of Research (WRAIR)

Timeline

Phase 1CompletedFinished

2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

First PostedFeb 2006

Enrollment StartJun 2006

Primary CompletionJan 2007

Study CompletionJan 2008

TodayJul 2026

First PostedFeb 16, 2006

Enrollment StartJun 12, 2006

Primary CompletionJan 17, 2007

Study CompletionJan 1, 2008

TodayJul 2, 2026

Enrollment to primary: 7 monthsPosted 20.4 years ago

Interventions

Intravenous Artesunatedrug

Three doses of Intravenous Artesunate drug at 2, 4, or 8 mg/kg in diluent Phosphate Buffer (0.3 M, pH 8.1)

Placebodrug

Mannitol (200 mg/vial) diluted in Phosphate Buffer and given IV in equivalent volume by subject's weight.