A Study to Assess the Tolerability, Safety, Pharmacodynamics, and Pharmacokinetics of Ascending Single Doses (Including Food Interaction) and Ascending Multiple Doses of ACT-453859, and Multiple Doses of Setipiprant (ACT-129968)

Phase 1 Completed 88 enrolled Idorsia Pharmaceuticals Ltd.

RandomizedParallel-groupTriple-blindOther

Summary

This is a three-part study to assess the tolerability, safety, pharmacodynamics, and pharmacokinetics of ascending single doses (including food interaction) of ACT-453859 in healthy male subjects, of ascending multiple doses of ACT-453859 in healthy male and female subjects, and of multiple doses of setipiprant (ACT-129968) in healthy male and female subjects.

Timeline

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

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ACT-453859	Unknown	1 mg	Oral
Subject	ACT-453859	Unknown	3 mg	Oral
Subject	ACT-453859	Unknown	10 mg	Oral
Subject	ACT-453859	Unknown	30 mg	Oral
Subject	ACT-453859	Unknown	100 mg	Oral
Subject	ACT-453859	Unknown	300 mg	Oral
Subject	ACT-453859	Unknown	800 mg	Oral
Subject	Setipiprant	Small molecule	500 mg	Oral
Subject	Setipiprant	Small molecule	1000 mg	Oral

Indications

No indication recorded.