HealthyPhase 1NCT03892902
A Clinical Study to Assess Next-day Driving Performance Following Administration of ACT-541468 in Middle-aged and Elderly Subjects
A Phase 1 study testing ACT-541468 and Zopiclone 7.5 mg in people with Healthy, run by Idorsia Pharmaceuticals Ltd. at 1 site in Netherlands.
Trial summary
A clinical study to assess next-day driving performance following evening administrations of ACT-541468 in middle-aged and elderly subjects Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ACT-541468 and Zopiclone 7.5 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 Mar 2019to 10 Oct 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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:
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
A clinical study to assess next-day driving performance following evening administrations of ACT-541468 in middle-aged and elderly subjects
- Conditions
- Healthy
- Being tested
- ACT-541468, Zopiclone 7.5 mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-541468Drug
Film-coated tablet for oral use at a dose strength of 50 mg.
Zopiclone 7.5 mgDrug
Over-encapsulated to maintain blinding.
PlaceboOther
Matching to maintain blinding.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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). Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: On Day 5 at 9 hours post dose. Duration of the test: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start25 Mar 2019
- Primary completion10 Oct 2019
- Study completion10 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 4-way cross-over study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Pharmacologist, Study director, Idorsia Pharmaceuticals Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892902
- Sponsor's protocol ID
- ID-078-108
- Status last verified
- Oct 2019
- First submitted
- 21 Mar 2019
- Last updated
- 31 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03892902
- Acronym / sponsor ID
- ID-078-108
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 10 Oct 2019 (actual)
- Study completion
- 10 Oct 2019 (actual)
- First posted
- 27 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A clinical study to assess next-day driving performance following evening administrations of ACT-541468 in middle-aged and elderly subjects
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 4-way cross-over study
| Arm | Type | Receives |
|---|---|---|
| Treatment A (50 mg ACT-541468) | Experimental | Drug: ACT-541468, Other: Placebo1 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) | Experimental | Drug: ACT-541468, Other: Placebo2 tablets of ACT-541468 50 mg + zopiclone matching placebo administered in the evening on Days 1-4 of Treatment Period B. |
| Treatment C (7.5 mg zopiclone) | Experimental | Drug: Zopiclone 7.5 mg, Other: Placebo2 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 D (placebo) | Experimental | Other: Placebo2 tablets of ACT-541468 matching placebo + zopiclone matching placebo administered in the evening on Days 1-4 of Treatment Period D. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
- Current or previous diagnosis of insomnia-related disorder according to the Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-5) criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT-541468Film-coated tablet for oral use at a dose strength of 50 mg. | Drug | Treatment A (50 mg ACT-541468), Treatment B (100 mg ACT-541468) |
| Zopiclone 7.5 mgOver-encapsulated to maintain blinding. | Drug | Treatment C (7.5 mg zopiclone) |
| PlaceboMatching to maintain blinding. | Other | Treatment A (50 mg ACT-541468), Treatment B (100 mg ACT-541468), Treatment C (7.5 mg zopiclone), Treatment D (placebo) |
Primary outcome
Pharmacodynamic endpoint: Driving performance as measured by the SDLB (difference from placebo, cm) using the Green Dino driving simulator - Day 2
Time frame: 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
Time frame: On Day 5 at 9 hours post dose. Duration of the test: 1 hour
SDLP = standard deviation of the lateral position
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Pharmacologist study director
Idorsia Pharmaceuticals Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ACT-541468 and Zopiclone 7.5 mg in people with Healthy, run by Idorsia Pharmaceuticals Ltd. at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacodynamic endpoint: Driving performance as measured by the SDLB (difference from placebo, cm) using the Green Dino driving simulator - Day 2 (time frame: On Day 2 at 9 hours post dose. Duration of the test: 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2019.