CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 11 enrolled
Drug / intervention
KAE609 +3 moredrug
Likely dose
KAE609 75mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT01860989
NCT01860989Phase 2Completed

An Open Label, Single Dose Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of KAE609 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum Malaria Mono-infection

Novartis Pharmaceuticals·interventional·Posted May 23, 2013·Updated Sep 10, 2015

In Brief

A Phase 2 clinical trial evaluating KAE609 for Cure Rate. Completed, enrolled 11 participants across 4 sites in 2 countries.

Detailed Summary

This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria patients with acute P. falciparum infection after single dose with KAE609 at 75 mg, 150mg, 225mg and 300mg/day

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCure Rate
CountriesThailand, Vietnam
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 23, 2013
Enrollment StartJul 1, 2013
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 13.1 years ago

Interventions

KAE609drug

KAE609 75mg single dose

KAE609drug

KAE609 150mg single dose

KAE609drug

KAE609 225mg single dose

KAE609drug

KAE609 300mg single dose