Study to Evaluate Safety and Tolerability of ACT-709478 in Healthy Subjects

Phase 1 Completed 46 enrolled Idorsia Pharmaceuticals Ltd.

RandomizedParallel-groupQuadruple-blindOther

Summary

The primary purpose of this study is to evaluate the safety and tolerability of ascending multiple doses of ACT-709478 in healthy male and female subjects

Timeline

Start: 2017-07-07
Primary completion: 2018-11-15
Completion: 2018-12-28

Publications

Richard M, Kaufmann P, Ort M, Kornberger R, Dingemanse J. Multiple-Ascending Dose Study in Healthy Subjects to Assess the Pharmacokinetics, Tolerability, and CYP3A4 Interaction Potential of the T-Type Calcium Channel Blocker ACT-709478, A Potential New Antiepileptic Drug. CNS Drugs. 2020 Mar;34(3):311-323. doi: 10.1007/s40263-019-00697-1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	APINOCALTAMIDE	Small molecule	10 mg	Oral
Subject	APINOCALTAMIDE	Small molecule	30 mg	Oral
Subject	APINOCALTAMIDE	Small molecule	60 mg	Oral
Subject	APINOCALTAMIDE	Small molecule	100 mg	Oral
Subject	APINOCALTAMIDE	Small molecule	200 mg	Oral
Subject	Midazolam	Small molecule	4 mg	Oral

Indications

No indication recorded.