Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT-451840 in Healthy Subjects (Part A)

Phase 1 Completed 40 enrolled Idorsia Pharmaceuticals Ltd.

RandomizedParallel-groupTriple-blindOther

Summary

The primary objective of the study was to evaluate the safety and tolerability of ACT-451840 in healthy male subjects.Secondary objectives were : to investigate the pharmacokinetics (PK) of ACT-451840; to investigate the effect of food on the PK of ACT-451840; to evaluate the urinary excretion of ACT-451840 and to investigate the antimalarial activity of ACT-451840.

Timeline

Start: 2011-12
Primary completion: 2012-04
Completion: 2012-04

Publications

Bruderer S, Hurst N, de Kanter R, Miraval T, Pfeifer T, Donazzolo Y, Dingemanse J. First-in-humans study of the safety, tolerability, and pharmacokinetics of ACT-451840, a new chemical entity with antimalarial activity. Antimicrob Agents Chemother. 2015 Feb;59(2):935-42. doi: 10.1128/AAC.04125-14. Epub 2014 Nov 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ACT-451840	Small molecule	10 mg	Oral
Subject	ACT-451840	Small molecule	50 mg	Oral
Subject	ACT-451840	Small molecule	200 mg	Oral
Subject	ACT-451840	Small molecule	500 mg	Oral
Subject	ACT-451840	Small molecule	1000 mg	Oral

Indications

No indication recorded.