Safety Study on the Effect of Eurartesim™ on QT/QTc Interval Compared to Riamet in Healthy Volunteers

Malaria, Falciparum Clinical Trial

Official title: Phase I, Randomized, Parallel Group Study to Evaluate the Effect of Multiple Oral Doses of Eurartesim on the QT/QTc Interval Compared to Riamet, Placebo and Moxifloxacin in Healthy Male and Female Volunteers

Status Completed

Clinical Trial Summary

The aim of such a study is to evaluate the impact of a therapeutic dose of Eurartesim™ compared to Riamet®, after multiple dose administration for 3 days in healthy male and female subjects on electrocardiographic parameters.

Clinical Trial Description

The fight against malaria, which the WHO reactivated in 1999 with its Roll Back Malaria programme, emphasizes early curative treatment of malaria, particularly in children, in order to decrease mortality and morbidity. Recent estimates confirm a disturbing persistence of endemic malaria with around 515 million cases and 1.0 million deaths per year.The available range of standard antimalarial drugs is narrow. There are only four classes of compounds, probably with different mechanisms of action: 4-aminoquinolines, amino-alcohols, artemisinin derivatives (isolated from a plant, Artemisia annua), and antifolates and drugs related to them.

From a public health perspective, drug resistance is a critical factor that undermines malaria control.Plasmodium falciparum and resistance to chloroquine and sulfadoxine/pyrimethamine is widespread. At present, natural quinine is still effective against P. falciparum everywhere in the world except partially in South-east Asia and South America, where decreased susceptibility is reported. Only the artemisinin derivatives, used for 15 years in Asia and, more recently in Africa, have not generated clinical resistance. Overcoming or reducing resistance requires the adoption of several strategies; central to these is the use of effective chemotherapy for those who need it. In addition, to new molecules, we need to develop and implement strategies to protect drugs against resistance. Resistance to single-drug therapies will inevitably occur. Drug combinations, which have been standard practice for viral and bacterial diseases, are now being adopted for malaria as well. The artemisinin derivatives in combination with standard antimalarials are now being promoted as the best therapeutic option for treating drug-resistant malaria and retarding the development of resistance.

The aim of the present study is to investigate the effect of this new Artemisinin Combination Therapy (ACT) formulation on electrocardiographic parameters. In the literature no relevant QT prolongation associated with Piperaquine treatment has been reported in not-company sponsored trials but no specific TQT trials have been published. On the contrary it has been reported that quinine, quinidine and halofantrine induced a QT prolongation (from slight to severe). ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria, Falciparum

• NCT number: NCT01103830
• Study type: Interventional
• Source: sigma-tau i.f.r. S.p.A.
• Status: Completed
• Phase: Phase 1
• Start date: February 2010
• Completion date: December 2010