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

Malaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00563914
• Other study ID #: ACT10420
• Secondary ID: SSR97193
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 22, 2007
• Last updated: December 18, 2009
• Start date: October 2007
• Est. completion date: November 2008

Study information

• Verified date: December 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Gabon : Comité d'Ethique
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• ferroquine (SSR97193)
associated with artesunate
• amodiaquine
associated with artesunate

Locations

Country	Name	City	State
Gabon	Sanofi-Aventis Administrative Office	Lambaréné
Kenya	Sanofi-Aventis Administrative Office	Nairobi

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Gabon,  Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatic safety :ALT, AST, Alkaline Phosphatase, Total Bilirubin		Sreening , baseline, days D3,D5,D6,D7,D9,D14,D21 and D28	Yes
Secondary	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	No
Secondary	Pharmacokinetics of ferroquine assessed by repeated measurement of blood concentration		up to 28 days after last dosing	No