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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03892902
• Other study ID #: ID-078-108
• Status: Completed
• Phase: Phase 1
• Start date: March 25, 2019
• Est. completion date: October 10, 2019

Study information

• Verified date: October 2019
• Source: Idorsia Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 10, 2019
• Est. primary completion date: October 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria

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).

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ACT-541468
Film-coated tablet for oral use at a dose strength of 50 mg.
• Zopiclone 7.5 mg
Over-encapsulated to maintain blinding.

Other:
• Placebo
Matching to maintain blinding.

Locations

Country	Name	City	State
Netherlands	Centre for Human Drug Research	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
Idorsia Pharmaceuticals Ltd.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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