CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 152 target
Drug / intervention
6-diazo-5-oxo-L-norleucine (DON) +2 moredrug
Likely dose
6-diazo-5-oxo-L-norleucine (DON) 10 mg/kgfrom record
Key inclusion· 21
  • ✓Age 18 years or older for adults (Arm 1 and 2)
  • ✓Age 12 months to 14 years for children with cerebral malaria (Arm 3)
  • ✓Informed consent obtained and ICF signed
  • ✓BMI 18.5-25 kg/m2 for healthy adults and uncomplicated malaria
Key exclusion· 10
  • ✕Pregnancy or lactation
  • ✕Attempting to become pregnant
  • ✕Currently taking highly active antiretroviral therapy (HAART)
  • ✕Currently taking anti-tuberculosis medications

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

Search/NCT05478720
NCT05478720Phase 2RecruitingOn Track
Long Recruiting
CompareCT.gov

DON in Pediatric Cerebral Malaria: A Phase I/IIa Dose-Escalation Safety Study

Douglas Postels, MD, MS·interventional·Posted Jul 28, 2022·Updated Jun 29, 2026

In Brief

A Phase 2 clinical trial evaluating 6-diazo-5-oxo-L-norleucine (DON) and Placebo for Malaria, Cerebral. Currently recruiting, targeting 152 participants across 2 sites.

Detailed Summary

The goal of this clinical trial is to evaluate the safety of a single intravenous dose of DON in healthy adults, adults with uncomplicated malaria, and children 12 months-14 years old with clinically defined Cerebral Malaria. The main objectives are: * Evaluate the safety of a single intravenous dose of DON in healthy adults and adults with uncomplicated malaria ( Part 1) * Determine the safety of a single dose of DON in children 12 months-14 years old with World Health Organization (WHO) clinically defined CM (Part 2 :Cohort 1-4) * Determine the pharmacokinetic (PK) profile of a single dose of DON in healthy adults, adults with uncomplicated malaria and children with CM (Part 1, and Cohorts 1-4 of Part 2) * Determine if administration of a single intravenous dose of DON as an adjunctive therapy in children with CM is associated with improved intracerebral blood flow dynamics on transcranial doppler (TCD) (Part 2 :Cohort 1-4) * Determine if administration of a single intravenous dose of DON as an adjunctive therapy in children with CM is associated with a reduction in brain volume score on magnetic resonance imaging (MRI) (Part 2 :Cohort 1-4) * Determine if administration of a single intravenous dose of DON as an adjunctive therapy in children with cerebral malaria is associated with changes in electroencephalogram (EEG) pattern (Part 2 :Cohort 1-4) * Exploratory: Explore the metabolic mechanisms of action of adjunctive DON in children with CM Healthy adult participants will receive: * anti-emetic ondansetron * one dose of DON Adults with uncomplicated malaria will receive: * anti-emetic ondansetron * one dose of DON * artemisinin-combination therapies per Malawi Ministry of Health guidelines Pediatric participants will receive: * one dose of DON * anti-emetic ondansetron and per Malawi Ministry of Health guidelines: * enteral lumefantrine-artemether therapy, and * artesunate therapy

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria, Cerebral
CountriesMalawi
CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID)

Timeline

Phase 2Recruiting
20232024202520262027
First PostedJul 28, 2022
Enrollment StartAug 16, 2022
Primary CompletionDec 1, 2026
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 3.9 years agoPrimary completion in 5 months

Interventions

6-diazo-5-oxo-L-norleucine (DON)drug

Single intravenous dose ranging from 0.1-10 mg/kg per dose

Placebodrug

Single intravenous dose of saline

6-diazo-5-oxo-L-norleucine (DON)drug

Single intravenous dose ranging from 0.1-1.0 mg/kg per dose