HealthyPhase 1NCT05572281
Bioequivalence Study Between Tasimelteon Capsule Formulation and Liquid Suspension Formulation in Healthy Volunteers
A Phase 1 study testing Tasimelteon Oral Capsule and Tasimelteon Oral Suspension in people with Healthy, run by Vanda Pharmaceuticals at 1 site in United States.
Trial summary
This is a single center, two-period, randomized study to evaluate the bioequivalence of a single dose of tasimelteon capsule formulation relative to a single dose of liquid suspension formation in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Tasimelteon Oral Capsule and Tasimelteon Oral Suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2022to 15 Jun 2022
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and/or female participants between 18 to 55 years (inclusive).
- Good health as determined by no clinically significant deviations from normal in medical history, clinical laboratory determination, ECGs, and physical examinations conducted during the screening visit.
- Participants with no clinically significant medical, psychiatric or sleep disorders as determined by the PI.
Who cannot join
- Participants with history of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations.
- Participants who suffered from significant physical illness (required hospitalization) in the 4-week period preceding baseline will be excluded.
- Participants with history of smoking or use of tobacco products in the last 3 months.
- Pregnant or nursing (lactating) women.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanda Investigational Site
Springfield, Missouri, 65802
About this study
Official title: An Open-Label, Two-Period, Randomized, Single Oral Dose, Crossover Study to Evaluate the Bioequivalence of Tasimelteon Capsule Formulation Relative to Tasimelteon Liquid Suspension Formulation in Healthy Volunteers
This is a single center, two-period, randomized study to evaluate the bioequivalence of a single dose of tasimelteon capsule formulation relative to a single dose of liquid suspension formation in healthy volunteers.
- Conditions
- Healthy
- Being tested
- Tasimelteon Oral Capsule, Tasimelteon Oral Suspension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tasimelteon Oral CapsuleDrug
No additional information
Tasimelteon Oral SuspensionDrug
No additional information
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | tasimelteon liquid suspension formulation then tasimelteon capsule formulation Receives: Drug: Tasimelteon Oral Capsule; Drug: Tasimelteon Oral Suspension |
| Sequence B | Experimental | tasimelteon capsule formulation then tasimelteon liquid suspension formulation Receives: Drug: Tasimelteon Oral Capsule; Drug: Tasimelteon Oral Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence between tasimelteon capsule formulation relative to tasimelteon liquid suspension formulation
as measured by plasma concentrations
Measured: 8 hours
Assessment of Safety and Tolerability of the liquid suspension and capsule formulation of tasimelteon
as measured by incidence of adverse events and clinically significant changes in laboratory values, ECG parameters, and vital signs
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start18 May 2022
- Primary completion15 Jun 2022
- Study completion15 Jun 2022
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT05572281
- Sponsor's protocol ID
- VP-VEC-162-1113
- Status last verified
- Mar 2024
- First submitted
- 5 Jul 2022
- Last updated
- 21 Mar 2024
- Results posted
- 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 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Two-Period, Randomized, Single Oral Dose, Crossover Study to Evaluate the Bioequivalence of Tasimelteon Capsule Formulation Relative to Tasimelteon Liquid Suspension Formulation in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05572281
- Acronym / sponsor ID
- VP-VEC-162-1113
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 18 May 2022 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 7 Oct 2022 (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.
This is a single center, two-period, randomized study to evaluate the bioequivalence of a single dose of tasimelteon capsule formulation relative to a single dose of liquid suspension formation in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Drug: Tasimelteon Oral Capsule, Drug: Tasimelteon Oral Suspensiontasimelteon liquid suspension formulation then tasimelteon capsule formulation |
| Sequence B | Experimental | Drug: Tasimelteon Oral Capsule, Drug: Tasimelteon Oral Suspensiontasimelteon capsule formulation then tasimelteon liquid suspension formulation |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male and/or female participants between 18 to 55 years (inclusive).
- Good health as determined by no clinically significant deviations from normal in medical history, clinical laboratory determination, ECGs, and physical examinations conducted during the screening visit.
- Participants with no clinically significant medical, psychiatric or sleep disorders as determined by the PI.
Key exclusion criteria (4 listed)
- Participants with history of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations.
- Participants who suffered from significant physical illness (required hospitalization) in the 4-week period preceding baseline will be excluded.
- Participants with history of smoking or use of tobacco products in the last 3 months.
- Pregnant or nursing (lactating) women.
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 |
|---|---|---|
| Tasimelteon Oral CapsuleNo additional information | Drug | Sequence A, Sequence B |
| Tasimelteon Oral SuspensionNo additional information | Drug | Sequence A, Sequence B |
Primary outcome
Bioequivalence between tasimelteon capsule formulation relative to tasimelteon liquid suspension formulation
Time frame: 8 hours
as measured by plasma concentrations
Assessment of Safety and Tolerability of the liquid suspension and capsule formulation of tasimelteon
Time frame: 7 days
as measured by incidence of adverse events and clinically significant changes in laboratory values, ECG parameters, and vital signs
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.
- 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.
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 Oral Capsule and Tasimelteon Oral Suspension in people with Healthy, run by Vanda Pharmaceuticals at 1 site in United States.
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 3 inclusion and 4 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 United States. 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?
Bioequivalence between tasimelteon capsule formulation relative to tasimelteon liquid suspension formulation (time frame: 8 hours). 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 21 Mar 2024.