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

NCT03892902 | Completed Phase 1 FDA Drug

• 1 other identifier: ID-078-108
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Pharmacodynamic endpoint: Driving performance as measured by the SDLB (difference from placebo, cm) using the Green Dino driving simulator - Day 2

  SDLP = standard deviation of the lateral position

  On Day 2 at 9 hours post dose. Duration of the test: 1 hour

• Pharmacodynamic endpoint: Driving performance as measured by the SDLB (difference from placebo, cm) using the Green Dino driving simulator - Day 5

  SDLP = standard deviation of the lateral position

  On Day 5 at 9 hours post dose. Duration of the test: 1 hour

Study Arms (4)

Treatment A (50 mg ACT-541468)

EXPERIMENTAL

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.

Drug: ACT-541468; Other: Placebo

Treatment B (100 mg ACT-541468)

EXPERIMENTAL

2 tablets of ACT-541468 50 mg + zopiclone matching placebo administered in the evening on Days 1-4 of Treatment Period B.

Drug: ACT-541468; Other: Placebo

Treatment C (7.5 mg zopiclone)

EXPERIMENTAL

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).

Drug: Zopiclone 7.5 mg; Other: Placebo

Treatment D (placebo)

EXPERIMENTAL

2 tablets of ACT-541468 matching placebo + zopiclone matching placebo administered in the evening on Days 1-4 of Treatment Period D.

Other: Placebo

Interventions

ACT-541468 DRUG

Film-coated tablet for oral use at a dose strength of 50 mg.

Treatment A (50 mg ACT-541468); Treatment B (100 mg ACT-541468)

Zopiclone 7.5 mg DRUG

Over-encapsulated to maintain blinding.

Treatment C (7.5 mg zopiclone)

Placebo OTHER

Matching to maintain blinding.

Treatment A (50 mg ACT-541468); Treatment B (100 mg ACT-541468); Treatment C (7.5 mg zopiclone); Treatment D (placebo)

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• General criteria:
• Signed informed consent prior to any study-mandated procedure.
• Male and female subjects aged between 50 and 80 years (inclusive) at Screening.
• Women of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1 pre-dose of each treatment period. They must consistently and correctly use a highly effective method of contraception, be sexually inactive, or have a vasectomized partner.
• Women of non-childbearing potential (i.e., postmenopausal, XY genotype, Turner syndrome, uterine agenesis).
• Study-specific criteria
• Subject has a valid driving license for more than 5 years, has driven at least 3000 km/year on average in the past 2 years.
• Normal visual acuity (corrected or uncorrected).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Idorsia Pharmaceuticals Ltd.: lead

Study Sites (1)

Centre for Human Drug Research

Leiden, 2333, Netherlands

Location

MeSH Terms

Interventions

daridorexant; zopiclone

Study Officials

• Clinical Pharmacologist

  Idorsia Pharmaceuticals Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 4-way cross-over study

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: March 27, 2019
• Study Start: March 25, 2019
• Primary Completion: October 10, 2019
• Study Completion: October 10, 2019
• Last Updated: October 31, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)