Healthy VolunteersPhase 1NCT06323655
Evaluation of Next-Day Residual Effects of Tasimelteon Compared With Placebo and Active Control in Healthy Subjects
A Phase 1 study testing Tasimelteon in people with Healthy Volunteers, run by Vanda Pharmaceuticals at 1 site in Canada.
Trial summary
The aim of this study is to investigate next-day residual effects of tasimelteon compared with placebo and active control in healthy subjects. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Tasimelteon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- 19 Jul 2018to 28 Aug 2018
- 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ability to provide written consent;
- Healthy subjects with no medical, psychiatric, or current sleep disorders;
- Men and women ages 21 - 55, inclusive;
- Possession of a valid driver's license ≥ 3 years with reported annual mileage ≥ 3,000 km.
Who cannot join
- Pregnancy or recent pregnancy;
- Subjects who are unable to read or speak English or French.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Double-dummy, Placebo-controlled, Three-way Crossover Study in Healthy Subjects to Evaluate the Next-day Residual Effects of 20 mg Tasimelteon
The aim of this study is to investigate next-day residual effects of tasimelteon compared with placebo and active control in healthy subjects.
- Conditions
- Healthy Volunteers
- Being tested
- Tasimelteon, Active Control Placebo, Tasimelteon Placebo, Active Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TasimelteonDrug
oral capsule
Active Control PlaceboDrug
oral capsule
Tasimelteon PlaceboDrug
oral capsule
Active ControlDrug
oral capsule
| Study group | Role | What they receive |
|---|---|---|
| Tasimelteon | Experimental | single dose Receives: Drug: Tasimelteon; Drug: Active Control Placebo |
| Placebo | Placebo comparator | single dose Receives: Drug: Active Control Placebo; Drug: Tasimelteon Placebo |
| Active Control | Active comparator | single dose Receives: Drug: Tasimelteon Placebo; Drug: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Next-day effects on simulated driving performance as measured by changes in Standard Deviation of Lateral Position (SDLP)
Measured: Day 1 of Treatment Period 1, Treatment Period 2, and Treatment Period 3 (each Period is 1 day, separated by washout)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start19 Jul 2018
- Primary completion28 Aug 2018
- Study completion28 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Vanda PharmaceuticalsThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323655
- Sponsor's protocol ID
- VP-VEC-162-1201
- Status last verified
- Mar 2024
- First submitted
- 18 Oct 2019
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Double-dummy, Placebo-controlled, Three-way Crossover Study in Healthy Subjects to Evaluate the Next-day Residual Effects of 20 mg Tasimelteon
- ClinicalTrials.gov ID
- NCT06323655
- Acronym / sponsor ID
- VP-VEC-162-1201
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2018 (actual)
- Primary completion
- 28 Aug 2018 (actual)
- Study completion
- 28 Aug 2018 (actual)
- First posted
- 21 Mar 2024 (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.
The aim of this study is to investigate next-day residual effects of tasimelteon compared with placebo and active control in healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tasimelteon | Experimental | Drug: Tasimelteon, Drug: Active Control Placebosingle dose |
| Placebo | Placebo comparator | Drug: Active Control Placebo, Drug: Tasimelteon Placebosingle dose |
| Active Control | Active comparator | Drug: Tasimelteon Placebo, Drug: Active Controlsingle dose |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Ability to provide written consent;
- Healthy subjects with no medical, psychiatric, or current sleep disorders;
- Men and women ages 21 - 55, inclusive;
- Possession of a valid driver's license ≥ 3 years with reported annual mileage ≥ 3,000 km.
Key exclusion criteria (2 listed)
- Pregnancy or recent pregnancy;
- Subjects who are unable to read or speak English or French.
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 |
|---|---|---|
| Tasimelteonoral capsule | Drug | Tasimelteon |
| Active Control Placebooral capsule | Drug | Placebo, Tasimelteon |
| Tasimelteon Placebooral capsule | Drug | Active Control, Placebo |
| Active Controloral capsule | Drug | Active Control |
Primary outcome
Next-day effects on simulated driving performance as measured by changes in Standard Deviation of Lateral Position (SDLP)
Time frame: Day 1 of Treatment Period 1, Treatment Period 2, and Treatment Period 3 (each Period is 1 day, separated by washout)
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 21 Mar 2024.
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Screening Protocol
Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Tasimelteon in people with Healthy Volunteers, run by Vanda Pharmaceuticals at 1 site in Canada.
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 4 inclusion and 2 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 21 Mar 2024. 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 Canada. 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. Some participants in this study may receive a placebo. 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?
Next-day effects on simulated driving performance as measured by changes in Standard Deviation of Lateral Position (SDLP) (time frame: Day 1 of Treatment Period 1, Treatment Period 2, and Treatment Period 3 (each Period is 1 day, separated by washout)). 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 21 Mar 2024.