Phase 1b Malaria Clinical Trial Using Argemone Mexicana in Healthy Adults in Mali

Malaria Clinical Trial

Official title: Phase 1b Clinical Trial Using Argemone Mexicana in Healthy Adults Infected or Not Infected With Plasmodium Falciparum in Mali: Pharmacokinetics and Observational Study

Status Active, not recruiting

Clinical Trial Summary

The main objective is to study the pharmacokinetics, pharmacodynamics and tolerability of the decoction of the aerial parts of Argemone mexicana (AM), administered in healthy volunteers.

Clinical Trial Description

This is an open non comparative safety and pharmacokinetic (PK) study clinical trial. Healthy volunteers aged from 18 to 50 years old will be recruited and followed 42 days after treatment initiation as in the current World Health Organization malaria drug protocol efficacy assessment protocol.

Each volunteer will be take oral Argemone mexicana in decoction formulation. For the PK assessment purposes, 3 groups have been constituted: (i) a group will receive a unique dose of with blood withdrawal scheduled at 0 hour, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hour , 8 hours and 12 hours. (ii) a group will receive two doses (morning and evening) of Argemone mexicana for 14 days with blood withdrawal scheduled at 0 hours, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 3 days, 7 days and 14 days. (iii) a group will receive two doses (morning and evening) of Argemone mexicana for 14 days with blood withdrawal scheduled at 0 hour, 12 hours, 14 hours, 16 hours, 18 hours, 20 hours, 22 hours, 24 hours, 3 days, 7 days, 14 days and 21 days Safety will be assessed clinically (Clinical exam and Electrocardiography) and biologically (hematology and biochemistry parameters will be measured) throughout the 42 days of thefollow-up. ;

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Malaria

• NCT number: NCT01645254
• Study type: Interventional
• Source: University of Bamako
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: September 2012
• Completion date: November 2012