NCT00563914

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2007

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 26, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

December 21, 2009

Status Verified

December 1, 2009

Enrollment Period

1.1 years

First QC Date

November 22, 2007

Last Update Submit

December 18, 2009

Conditions

Malaria

Keywords

Malaria

Outcome Measures

Primary Outcomes (1)

  • Hepatic safety :ALT, AST, Alkaline Phosphatase, Total Bilirubin

    Sreening , baseline, days D3,D5,D6,D7,D9,D14,D21 and D28

Secondary Outcomes (2)

  • 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

Study Arms (2)

1

EXPERIMENTAL
Drug: ferroquine (SSR97193)

2

ACTIVE COMPARATOR
Drug: amodiaquine

Interventions

ferroquine (SSR97193)DRUG

associated with artesunate

1
amodiaquineDRUG

associated with artesunate

2

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sanofi-Aventis Administrative Office

Lambaréné, Gabon

Location

Sanofi-Aventis Administrative Office

Nairobi, Kenya

Location

Related Publications (1)

  • Supan C, Mombo-Ngoma G, Kombila M, Ospina Salazar CL, Held J, Lell B, Cantalloube C, Djeriou E, Ogutu B, Waitumbi J, Otsula N, Apollo D, Polhemus ME, Kremsner PG, Walsh DS. Phase 2a, Open-Label, 4-Escalating-Dose, Randomized Multicenter Study Evaluating the Safety and Activity of Ferroquine (SSR97193) Plus Artesunate, versus Amodiaquine Plus Artesunate, in African Adult Men with Uncomplicated Plasmodium falciparum Malaria. Am J Trop Med Hyg. 2017 Aug;97(2):514-525. doi: 10.4269/ajtmh.16-0731. Epub 2017 Jul 19.

    PMID: 28722611DERIVED

MeSH Terms

Conditions

Malaria

Interventions

ferroquineAmodiaquine

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Christian Supan, MD

    URM (Unité de Recherches Médicales), Hôpital Albert Schweitzer, BP 118 Lambaréné, Gabon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 22, 2007

First Posted

November 26, 2007

Study Start

October 1, 2007

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

December 21, 2009

Record last verified: 2009-12

Locations

KE(1)GA(1)