Dose Ranging Study of Ferroquine With Artesunate in African Adults and Children With Uncomplicated Plasmodium Falciparum Malaria

Summary

Primary objective: To assess the Day 28 efficacy defined as the percentage of patients with no parasitic recrudescence, of 3 treatment groups - 3 dose levels of ferroquine associated with artesunate - for a 3-day treatment. Secondary objectives: * To assess the efficacy of ferroquine at one dose level alone for a 3-day treatment. * To assess the clinical safety of 4 treatment groups - 3 dose levels of ferroquine associated with artesunate and one dose level of ferroquine alone. * To assess pharmacokinetics parameters of ferroquine and its metabolites along sparse sampling schedules.

Timeline

Start

2009-10

Primary completion

2010-11

Completion

2010-11

Outcome

Met primary endpoint

Stopped (Business): “Company decision to modify the ferroquine development strategy; discontinuation not due to safety or activity unexpected findings”

paper The three dose groups of ferroquine plus artesunate met the non-inferiority hypothesis. PMID 26342427 ↗

Publications

• Held J, Supan C, Salazar CL, Tinto H, Bonkian LN, Nahum A, Moulero B, Sie A, Coulibaly B, Sirima SB, Siribie M, Otsyula N, Otieno L, Abdallah AM, Kimutai R, Bouyou-Akotet M, Kombila M, Koiwai K, Cantalloube C, Din-Bell C, Djeriou E, Waitumbi J, Mordmuller B, Ter-Minassian D, Lell B, Kremsner PG. Ferroquine and artesunate in African adults and children with Plasmodium falciparum malaria: a phase 2, multicentre, randomised, double-blind, dose-ranging, non-inferiority study. Lancet Infect Dis. 2015 Dec;15(12):1409-19. doi: 10.1016/S1473-3099(15)00079-1. Epub 2015 Sep 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Artesunate	Small molecule	4 mg/kg	Oral
Subject	Ferroquine	Small molecule	2 mg/kg	Oral
Subject	Ferroquine	Small molecule	4 mg/kg	Oral
Subject	Ferroquine	Small molecule	6 mg/kg	Oral

Indications