A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of ACT-541468 in Healthy Young Adults and Elderly Subjects

Phase 1 Completed 85 enrolled Idorsia Pharmaceuticals Ltd.

RandomizedParallel-groupQuadruple-blindOther

Summary

The purpose of this study is to evaluate the tolerability, safety, pharmacokinetics (PK, or amount of drug over time in the body) and pharmacodynamics (PD, or effects on the body) of ACT-541468 following multiple ascending doses in healthy adults and following single ascending doses in healthy elderly subjects when administered in the morning. The safety, PK and PD of ACT-541468 will also be assessed after repeated evening administration of a selected dose in both healthy adults and elderly.

Timeline

Start: 2015-10-01
Primary completion: 2016-02-01
Completion: 2016-02-01

Publications

Muehlan C, Boehler M, Brooks S, Zuiker R, van Gerven J, Dingemanse J. Clinical pharmacology of the dual orexin receptor antagonist ACT-541468 in elderly subjects: Exploration of pharmacokinetics, pharmacodynamics and tolerability following single-dose morning and repeated-dose evening administration. J Psychopharmacol. 2020 Mar;34(3):326-335. doi: 10.1177/0269881119882854. Epub 2019 Oct 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Daridorexant	Small molecule	5 mg	—
Subject	Daridorexant	Small molecule	10 mg	—
Subject	Daridorexant	Small molecule	15 mg	—
Subject	Daridorexant	Small molecule	25 mg	—
Subject	Daridorexant	Small molecule	75 mg	—

Indications

No indication recorded.