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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01645254
• Other study ID #: MRTC_Arge01
• Secondary ID: MRTC_Arge01
• Status: Active, not recruiting
• Phase: Phase 1
• First received: July 3, 2012
• Last updated: October 1, 2012
• Start date: September 2012
• Est. completion date: November 2012

Study information

• Verified date: October 2012
• Source: University of Bamako
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mali: Ministry of Health
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: November 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• Argemone mexicana
30g, the powder decoction 2 times a day for 14 days

Locations

Country	Name	City	State
Mali	Malaria Research and Training Center, USTTB	Bamako

Sponsors (2)

Lead Sponsor	Collaborator
University of Bamako	University of Geneva, Switzerland

Country where clinical trial is conducted

Mali, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes