Safety, Tolerability, Pharmacokinetics and Efficacy of ARCO

NCT01930331 ↗

Phase 4 Completed 60 enrolled Ifakara Health Institute

RandomizedSingle-groupOpen-labelTreatment

Summary

Phase IV, single center, 2 arms randomized controlled, open label study. Study will be conducted over a period of 42 days to determine the safety, tolerability, pharmacokinetics and efficacy of ARCO.

Timeline

Start: 2014-01-07
Primary completion: 2014-07-27
Completion: 2015-06-01

Publications

Ali AM, Gausi K, Jongo SA, Kassim KR, Mkindi C, Simon B, Mtoro AT, Juma OA, Lweno ON, Gwandu CH, Bakari BM, Mbaga TA, Milando FA, Hamad A, Shekalaghe SA, Abdulla S, Denti P, Penny MA. Population Pharmacokinetics of Antimalarial Naphthoquine in Combination with Artemisinin in Tanzanian Children and Adults: Dose Optimization. Antimicrob Agents Chemother. 2022 May 17;66(5):e0169621. doi: 10.1128/aac.01696-21. Epub 2022 Apr 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	ARTENIMOL	Small molecule	20 mg	Oral
Comparator	ARTENIMOL	Small molecule	40 mg	Oral
Subject	Artemisinin	Small molecule	20 mg/kg	Oral
Subject	Artemisinin	Small molecule	1000 mg	Oral
Subject	naphthoquine	Unknown	8 mg/kg	Oral
Subject	naphthoquine	Unknown	400 mg	Oral
Comparator	piperaquine	Small molecule	160 mg	Oral
Comparator	piperaquine	Small molecule	320 mg	Oral

Safety, Tolerability, Pharmacokinetics and Efficacy of ARCO

Summary

Timeline

Publications

Drugs

Indications