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

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

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.

Study Overview

• Status: Unknown
• Conditions: Malaria
• Intervention / Treatment: Drug: Argemone mexicana

Detailed 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 Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Mali
  • Bamako, Mali, 1805
    • Malaria Research and Training Center, USTTB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age of 18-50 years old;
• be in good general health;
• be available for the duration of the study;
• agreement to participate in the study
• be a resident of the village known study;
• acceptance of the conservation laboratory specimens for future research.

Exclusion Criteria:

• Plasmodium falciparum infection with clinical manifestations;
• Presence of severe or complicated malaria;
• Acute medical condition;
• Any other medical condition that requires medical attention inconsistent with the study or interfere with the study;
• Severe medical conditions;
• Allergy to the product of the study,
• Pregnant women or nursing
• Taking a derivative product of the study or other known antimalarial within 14 days before enrollment.
• Refusal to participate

Study Plan

How is the study designed?

Design Details

• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Argemone mexicana; Argemone mexicana is traditional medicinal plant known as having an antimalarial activity. The aerial part of this plant is used. The decoction of the powder of the plant will be used.	Drug: Argemone mexicana; 30g, the powder decoction 2 times a day for 14 days; Other Names: traditional antimalarial

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Adverse Events	health volunteers will be assessed daily for 3 days and then on Day 7 and then weekly up to 6 weeks.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma concentration curves of the drug	The phramacokinetics measured will be performed depending on the treatment groups. Three different treatment groups have constituted, each group will be allocated a specific time point for PK assessment.	6 weeks

Collaborators and Investigators

• Sponsor: University of Bamako
• Collaborators: University of Geneva, Switzerland
• Investigators: Principal Investigator: Issaka Sagara, MD,MSPH, University of Bamako

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ANTICIPATED): October 1, 2012
• Study Completion (ANTICIPATED): November 1, 2012

Study Registration Dates

• First Submitted: July 3, 2012
• First Submitted That Met QC Criteria: July 17, 2012
• First Posted (ESTIMATE): July 20, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 3, 2012
• Last Update Submitted That Met QC Criteria: October 1, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: pharmacokinetics; healthy volunteers; malaria; Argemone mexicana
• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Malaria; Anti-Infective Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials
• Other Study ID Numbers: MRTC_Arge01 (OTHER: MRTC_Arge01)