Clinical Study to Assess the Pharmacokinetics, Safety, and Tolerability of ACT-129968 in Healthy Subjects

Phase 1 Completed 20 enrolled Idorsia Pharmaceuticals Ltd.

RandomizedCrossoverOpen-labelOther

Summary

To explore the pharmacokinetics (PK) of a single dose of two different formulations of ACT-129968, i.e., tablet versus capsule and to evaluate the safety and tolerability of a single dose of two different formulations of ACT-129968, i.e., tablet versus capsule.

Timeline

Start: 2011-07-01
Primary completion: 2011-07-01
Completion: 2011-07-01

Publications

Baldoni D, Mackie A, Gutierrez M, Theodor R, Dingemanse J. Setipiprant, a selective oral antagonist of human CRTH2: relative bioavailability of a capsule and a tablet formulation in healthy female and male subjects. Clin Ther. 2013 Nov;35(11):1842-8. doi: 10.1016/j.clinthera.2013.09.003. Epub 2013 Oct 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Setipiprant	Small molecule	500 mg	Oral

Indications

No indication recorded.