Phase 1b Malaria Clinical Trial Using Argemone Mexicana i... | NCT01645254

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

NCT01645254

Sponsor

University of Bamako

Status

Unknown status

Last Update Posted

Oct 3, 2012Estimated

Enrollment

24Estimated

Phase

Phase 1

Conditions

Malaria

Interventions

Argemone mexicana

Countries

Mali

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
MRTC_Arge01	Other Identifier	MRTC_Arge01

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Oct 2012Estimated

Completion Date

Nov 2012Estimated

First Submitted Date

Jul 3, 2012

First Submission Date that Met QC Criteria

Jul 17, 2012

First Posted Date

Jul 20, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2012

Last Update Posted Date

Oct 3, 2012Estimated

Name	Class
University of Geneva, Switzerland	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Argemone mexicana	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Argemone mexicana	Drug	30g, the powder decoction 2 times a day for 14 days	Argemone mexicana

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Issaka Sagara, MD,MSPH	University of Bamako	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Malaria Research and Training Center, USTTB		Bamako		1805	Mali

Condition Browse Module

MeSH Terms

ID	Term
D008288	Malaria

Ancestor Terms

ID	Term
D011528	Protozoan Infections
D010272	Parasitic Diseases
D007239	Infections
D000096724	Mosquito-Borne Diseases

Browse Leaves

Not provided

Browse Branches

Not provided