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

Phase 1

Completed

• Conditions: Malaria
• Interventions: Drug: ferroquine (SSR97193); Drug: amodiaquine

• Registration Number: NCT00563914
• Lead Sponsor: Sanofi

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-11-22
• Study First Submitted QC: 2007-11-22
• Study First Posted: 2007-11-26
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-18
• Last Update Posted: 2009-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 72

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ferroquine (SSR97193)	-
2	amodiaquine	-

Primary Outcome Measures

Name	Time	Method
Hepatic safety :ALT, AST, Alkaline Phosphatase, Total Bilirubin	Sreening , baseline, days D3,D5,D6,D7,D9,D14,D21 and D28

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇰🇪 Nairobi, Kenya