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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Zopiclone 7.5 mg; Drug: ACT-541468; Other: Placebo

• Registration Number: NCT03892902
• Lead Sponsor: Idorsia Pharmaceuticals Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-21
• Study Start: 2019-03-25
• Study First Submitted QC: 2019-03-26
• Study First Posted: 2019-03-27
• Status Verified: 2019-10
• Primary Completion: 2019-10-10
• Study Completion: 2019-10-10
• Last Update Submitted: 2019-10-30
• Last Update Posted: 2019-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Not provided

Exclusion Criteria

General criteria:

• Pregnant or lactating women.
• Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of the results.
• History or presence of rhythm disorders
• Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.

Study-specific criteria:

• Current or previous diagnosis of insomnia-related disorder according to the Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-5) criteria.
• History of alcoholism, drug abuse, or regular use of sedative drugs or hypnotics within 3 years prior to Screening.
• History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of more than 21 units or an average daily intake of more than 3 units (males), or defined as an average weekly intake of more than 14 units or an average daily intake of more than 2 units (females). One unit is equivalent to a half-pint (approx. 250 mL) of beer or 1 measure (25 mL) of spirits or 1 glass (125 mL) of wine.
• Modified Swiss Narcolepsy Scale total score < 0 at Screening or history of narcolepsy or cataplexy.
• Activities that disturb the circadian rhythm (e.g., working night shift, travelling across 3 time zones) within 2 weeks before (each) study treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment C (7.5 mg zopiclone)	Zopiclone 7.5 mg	2 tablets of ACT-541468 matching placebo + 1 capsule of zopiclone 7.5 mg administered in the evening on Days 1 and 4 of Treatment Period C. In the evenings of Days 2 and 3, subjects will receive placebo (i.e., 2 tablets of ACT-541468 matching placebo + zopiclone matching placebo).
Treatment A (50 mg ACT-541468)	Placebo	1 tablet of ACT-541468 50 mg + 1 tablet of ACT-541468 matching placebo + zopiclone matching placebo administered in the evening on Days 1-4 of Treatment Period A.
Treatment C (7.5 mg zopiclone)	Placebo	2 tablets of ACT-541468 matching placebo + 1 capsule of zopiclone 7.5 mg administered in the evening on Days 1 and 4 of Treatment Period C. In the evenings of Days 2 and 3, subjects will receive placebo (i.e., 2 tablets of ACT-541468 matching placebo + zopiclone matching placebo).
Treatment B (100 mg ACT-541468)	Placebo	2 tablets of ACT-541468 50 mg + zopiclone matching placebo administered in the evening on Days 1-4 of Treatment Period B.
Treatment D (placebo)	Placebo	2 tablets of ACT-541468 matching placebo + zopiclone matching placebo administered in the evening on Days 1-4 of Treatment Period D.
Treatment A (50 mg ACT-541468)	ACT-541468	1 tablet of ACT-541468 50 mg + 1 tablet of ACT-541468 matching placebo + zopiclone matching placebo administered in the evening on Days 1-4 of Treatment Period A.
Treatment B (100 mg ACT-541468)	ACT-541468	2 tablets of ACT-541468 50 mg + zopiclone matching placebo administered in the evening on Days 1-4 of Treatment Period B.

Primary Outcome Measures

Name	Time	Method
Pharmacodynamic endpoint: Driving performance as measured by the SDLB (difference from placebo, cm) using the Green Dino driving simulator - Day 2	On Day 2 at 9 hours post dose. Duration of the test: 1 hour	SDLP = standard deviation of the lateral position
Pharmacodynamic endpoint: Driving performance as measured by the SDLB (difference from placebo, cm) using the Green Dino driving simulator - Day 5	On Day 5 at 9 hours post dose. Duration of the test: 1 hour	SDLP = standard deviation of the lateral position

Trial Locations

Locations (1)

Centre for Human Drug Research; 🇳🇱 Leiden, Netherlands