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

NCT ID: NCT01645254

Last Updated: 2012-10-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2012-11-30

Brief 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.

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.

Conditions

Malaria

Keywords

healthy volunteers; pharmacokinetics; malaria; Argemone mexicana

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Argemone mexicana

Intervention Type: DRUG

30g, the powder decoction 2 times a day for 14 days

Interventions

Argemone mexicana

30g, the powder decoction 2 times a day for 14 days

Intervention Type: DRUG

Other Intervention Names

traditional antimalarial

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Geneva, Switzerland

OTHER

Sponsor Role: collaborator

University of Bamako

OTHER

Sponsor Role: lead

Responsible Party

Issaka Sagara, M.D., MSPH

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Issaka Sagara, MD,MSPH

Role: PRINCIPAL_INVESTIGATOR

University of Bamako

Locations

Malaria Research and Training Center, USTTB

Bamako, , Mali

Countries

Mali

Other Identifiers

MRTC_Arge01

Identifier Type: OTHER

Identifier Source: secondary_id

MRTC_Arge01

Identifier Type: -

Identifier Source: org_study_id