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

NCT03892902 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2019-10-31

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Idorsia Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • Clinical Pharmacologist · Idorsia Pharmaceuticals Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-25
Primary Completion
2019-10-10
Completion
2019-10-10
FDA Drug
Yes

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03892902 on ClinicalTrials.gov