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

Sponsor

Idorsia Pharmaceuticals Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT03892902

Collaborator

(none)

Enrollment

Location

Arms

6.5

Actual Duration (Months)

8.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: ACT-541468 Drug: Zopiclone 7.5 mg Other: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

4-way cross-over study4-way cross-over study

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

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

Actual Study Start Date :

Mar 25, 2019

Actual Primary Completion Date :

Oct 10, 2019

Actual Study Completion Date :

Oct 10, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment A (50 mg 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.	Drug: ACT-541468 Film-coated tablet for oral use at a dose strength of 50 mg. Other: Placebo Matching to maintain blinding.
Experimental: Treatment B (100 mg ACT-541468) 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 Film-coated tablet for oral use at a dose strength of 50 mg. Other: Placebo Matching to maintain blinding.
Experimental: Treatment C (7.5 mg zopiclone) 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 Over-encapsulated to maintain blinding. Other: Placebo Matching to maintain blinding.
Experimental: Treatment D (placebo) 2 tablets of ACT-541468 matching placebo + zopiclone matching placebo administered in the evening on Days 1-4 of Treatment Period D.	Other: Placebo Matching to maintain blinding.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre for Human Drug Research	Leiden		Netherlands	2333

Sponsors and Collaborators

Idorsia Pharmaceuticals Ltd.

Investigators

Study Director: Clinical Pharmacologist, Idorsia Pharmaceuticals Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Idorsia Pharmaceuticals Ltd.

ClinicalTrials.gov Identifier:

NCT03892902

Other Study ID Numbers:

ID-078-108

First Posted:

Mar 27, 2019

Last Update Posted:

Oct 31, 2019

Last Verified:

Oct 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Zopiclone

Study Results

No Results Posted as of Oct 31, 2019