NCT03892902

A Clinical Study to Assess Next-day Driving Performance Following Administration of ACT-541468 in Middle-aged and Elderly Subjects

A Single-center, Randomized, Double-blind, Double-dummy, Placebo- and Active-controlled, 4-way Cross-over Study to Assess Next-day Driving Performance Following Single and Multiple Evening Administrations of ACT-541468 in Middle-aged and Elderly Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Accepted

Summary

A clinical study to assess next-day driving performance following evening administrations of ACT-541468 in middle-aged and elderly subjects

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ACT-541468	Film-coated tablet for oral use at a dose strength of 50 mg.
DRUG	Zopiclone 7.5 mg	Over-encapsulated to maintain blinding.
OTHER	Placebo	Matching to maintain blinding.

Timeline

• Start date: 2019-03-25
• Primary completion: 2019-10-10
• Completion: 2019-10-10
• First posted: 2019-03-27
• Last updated: 2019-10-31

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated drug study