Clinical trial NCT01645254: Phase 1b Malaria Clinical Trial Using Argemone Mexicana in Healthy Adults in Mali
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Malaria
Keywords: healthy volunteers
pharmacokinetics
malaria
Argemone mexicana
Lead sponsor: University of Bamako
Sponsor class: OTHER
Collaborators: name: University of Geneva, Switzerland
First posted: 2012-07-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

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.

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

Primary outcomes:
measure: Number of Adverse Events
timeFrame: 6 weeks
Secondary outcomes:
measure: Plasma concentration curves of the drug
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Bamako
country: Mali
facility: Malaria Research and Training Center, USTTB
Study officials:
affiliation: University of Bamako
name: Issaka Sagara, MD,MSPH
role: PRINCIPAL_INVESTIGATOR
References: