Clinical trial NCT03892902: A Clinical Study to Assess Next-day Driving Performance Following Administration of ACT-541468 in Middle-aged and Elderly Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2019-03-27
Enrollment: 56
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 4-way cross-over study
Primary purpose: OTHER

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


Eligibility criteria: 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.

Primary outcomes:
measure: Pharmacodynamic endpoint: Driving performance as measured by the SDLB (difference from placebo, cm) using the Green Dino driving simulator - Day 2
timeFrame: On Day 2 at 9 hours post dose. Duration of the test: 1 hour
measure: Pharmacodynamic endpoint: Driving performance as measured by the SDLB (difference from placebo, cm) using the Green Dino driving simulator - Day 5
timeFrame: On Day 5 at 9 hours post dose. Duration of the test: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Centre for Human Drug Research
Study officials:
affiliation: Idorsia Pharmaceuticals Ltd.
name: Clinical Pharmacologist
role: STUDY_DIRECTOR
References: