A Comparative Safety and Activity Study With Ferroquine Associated With Artesunate Versus Amodiaquine Associated With Artesunate in African Adult Patients With Uncomplicated Malaria

Study Overview
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Brief Summary
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The primary objective is to assess the safety of different doses of ferroquine with artesunate (AS) in adult African patients with uncomplicated malaria. The secondary objectives are to assess activity in reducing parasitemia and the pharmacokinetics of ferroquine and its metabolites.

Detailed Description
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The study duration is 30 days including a 2 day screening period, a 3 day treatment period with a follow-up period of 25 days. Patients remain hospitalized 4 days.

Official Title
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An Open Label, 4 Escalating Dose, Randomized Multicentre Study Evaluating the Safety and Activity of Ferroquine Associated With Artesunate Versus a Positive Calibrator (Amodiaquine Associated With Artesunate) in African Adult Patients With Uncomplicated Malaria

Conditions
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Malaria

Intervention / Treatment
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* Drug: ferroquine (SSR97193)
* Drug: amodiaquine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body weight between 50 kg and 90 kg with Body Mass Index >18 kg/m² Presence of body temperature ≥ 37.5°C or history of fever within the last 24 hours Monoinfection with Plasmodium falciparum and parasitemia within the 100 to 200,000/microL Exclusion Criteria: Hypersensitivity to quinoleines or artesunate History or presence of any clinically significant disease or symptoms which, in the judgment of the investigator, might confuse the interpretation of the safety and efficacy information Splenectomized patients Laboratory parameters outside normal ranges Presence of HBs antigen, anti-HCV antibodies and anti-HIV 1&2 antibodies Cardio vascular and Electrocardiogram parameters outside normal values Presence of criteria of complicated malaria Permanent vomiting Previous treatment within 5 times the elimination half-life of any anti-malaria agents or with any marketed or investigational drugs (including St John's Wort) within 14 days before administration, or within 5 times the elimination half-life of that drug, whichever the longest, especially CYP3A and 2D6 main substrates Positive results on urine drug screen for anti-malaria agents (aminoquinolines) History of drug or alcohol abuse (alcohol consumption > 40 grams/day ; i. e. 2.5 beers of 33cl with 5 degrees of alcohol) Intention to use herbal medicine during the study period Immunization injection within last 15 days The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: ferroquine (SSR97193)<br>* associated with artesunate<br>|
| Active Comparator: 2<br> | Drug: amodiaquine<br>* associated with artesunate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatic safety :ALT, AST, Alkaline Phosphatase, Total Bilirubin |  | Sreening , baseline, days D3,D5,D6,D7,D9,D14,D21 and D28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parasite clearance assessed by repeated measurements of parasitemia |  | Sreening, days D1(T6 and T12),D2 (T0 and T6), D3( T0, T6 and T12) ,D4,D7,D14,D21and D28 | 
| Pharmacokinetics of ferroquine assessed by repeated measurement of blood concentration |  | up to 28 days after last dosing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malaria