HealthyPhase 1NCT03884491
A Study Investigating Formulations of Vortioxetine Applied Under the Tongue in Healthy Subjects
A Phase 1 study testing Vortioxetine IV, Vortioxetine SLA and Vortioxetine SLB in people with Healthy, run by H. Lundbeck A/S at 1 site in United Kingdom.
Trial summary
This study investigates formulations of vortioxetine applied under the tongue Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Vortioxetine IV, Vortioxetine SLA and Vortioxetine SLB
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Mar 2019to 22 Jul 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -The subject has a BMI ≥18.5 and ≤30.0 kg/m2 at the Screening Visit and at the Baseline Visit.
Who cannot join
- -The subject is identified or confirmed to be a CYP2D6 poor metabolizer (PM)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional, Open-label, Sequential-period Study Investigating the Pharmacokinetic Properties and Safety and Tolerability of Sublingual Formulations of Vortioxetine in Healthy Subjects
This study investigates formulations of vortioxetine applied under the tongue
Read the detailed description
Apart from the first two doses, the study design is flexible in terms of doses and pharmaceutical formulations and will be decided upon based on an evaluation of the safety and tolerability as well as plasma exposure obtained during the study.
- The study consists of 5 periods. Single-doses of vortioxetine will be administered in all periods.
- All subjects will receive the same pharmaceutical formulations of the same dose strength in the same period and sequence.
- In Period 1, each subject will receive an intravenous (IV) 10 mg dose of vortioxetine infused over 2 hours. The exposure obtained after IV administration will serve as the reference for the sublingually administered dosage forms.
- In Period 2, each subject will receive 5 mg of formulation A (SLA) of vortioxetine in a sublingual (SL) formulation with a holding time of 90 seconds. The holding time is the time where swallowing of saliva should be avoided.
- For the 3 remaining dosing periods, one or more of the following options in pharmaceutical formulation, dose, and dosing condition apply to this study:
- Increases or decreases in dose (≤25mg) using same formulation
- Change from formulation SLA to formulation SLB
- Change in the holding time
- Change to formulation SLC
- Change in swallowing technique of the sublingual dosage forms
- Conditions
- Healthy
- Being tested
- Vortioxetine IV, Vortioxetine SLA, Vortioxetine SLB, Vortioxetine SLC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vortioxetine IVDrug
an intravenous (IV) 10 mg dose (1 mg/mL) of vortioxetine infused over 2 hours
Vortioxetine SLADrug
5-25 mg of sublingual formulation A of vortioxetine
Vortioxetine SLBDrug
5-25 mg of sublingual formulation B of vortioxetine
Vortioxetine SLCDrug
formulation SLC: solution of vortioxetine, concentrate (12.5 mg/mL-62,5 mg/mL) 200 uL or 400 uL, SL, 5-25 mg
| Study group | Role | What they receive |
|---|---|---|
| Vortioxetine | Experimental | Not described Receives: Drug: Vortioxetine IV; Drug: Vortioxetine SLA; Drug: Vortioxetine SLB; Drug: Vortioxetine SLC |
What is being measured
The primary outcome is the main question the study is designed to answer.
absolute bioavailability (F)
absolute bioavailability of vortioxetine for the sublingual administrations
Measured: From predose to 72 hours post dose
tmax
time to maximum plasma concentration (tmax)
Measured: From predose to 72 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start18 Mar 2019
- Primary completion25 Jun 2019
- Study completion22 Jul 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.
- More trials run by H. Lundbeck A/SThe 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
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@Lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884491
- Sponsor's protocol ID
- 18026A
- Status last verified
- Jul 2019
- First submitted
- 19 Mar 2019
- Last updated
- 1 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Open-label, Sequential-period Study Investigating the Pharmacokinetic Properties and Safety and Tolerability of Sublingual Formulations of Vortioxetine in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03884491
- Acronym / sponsor ID
- 18026A
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 25 Jun 2019 (actual)
- Study completion
- 22 Jul 2019 (actual)
- First posted
- 21 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.
This study investigates formulations of vortioxetine applied under the tongue
Detailed description
Apart from the first two doses, the study design is flexible in terms of doses and pharmaceutical formulations and will be decided upon based on an evaluation of the safety and tolerability as well as plasma exposure obtained during the study.
- The study consists of 5 periods. Single-doses of vortioxetine will be administered in all periods.
- All subjects will receive the same pharmaceutical formulations of the same dose strength in the same period and sequence.
- In Period 1, each subject will receive an intravenous (IV) 10 mg dose of vortioxetine infused over 2 hours. The exposure obtained after IV administration will serve as the reference for the sublingually administered dosage forms.
- In Period 2, each subject will receive 5 mg of formulation A (SLA) of vortioxetine in a sublingual (SL) formulation with a holding time of 90 seconds. The holding time is the time where swallowing of saliva should be avoided.
- For the 3 remaining dosing periods, one or more of the following options in pharmaceutical formulation, dose, and dosing condition apply to this study:
- Increases or decreases in dose (≤25mg) using same formulation
- Change from formulation SLA to formulation SLB
- Change in the holding time
- Change to formulation SLC
- Change in swallowing technique of the sublingual dosage forms
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vortioxetine | Experimental | Drug: Vortioxetine IV, Drug: Vortioxetine SLA, Drug: Vortioxetine SLB, Drug: Vortioxetine SLC |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -The subject has a BMI ≥18.5 and ≤30.0 kg/m2 at the Screening Visit and at the Baseline Visit.
Key exclusion criteria (1 listed)
- -The subject is identified or confirmed to be a CYP2D6 poor metabolizer (PM)
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 |
|---|---|---|
| Vortioxetine IVan intravenous (IV) 10 mg dose (1 mg/mL) of vortioxetine infused over 2 hours | Drug | Vortioxetine |
| Vortioxetine SLA5-25 mg of sublingual formulation A of vortioxetine | Drug | Vortioxetine |
| Vortioxetine SLB5-25 mg of sublingual formulation B of vortioxetine | Drug | Vortioxetine |
| Vortioxetine SLCformulation SLC: solution of vortioxetine, concentrate (12.5 mg/mL-62,5 mg/mL) 200 uL or 400 uL, SL, 5-25 mg | Drug | Vortioxetine |
Primary outcome
absolute bioavailability (F)
Time frame: From predose to 72 hours post dose
absolute bioavailability of vortioxetine for the sublingual administrations
tmax
Time frame: From predose to 72 hours post dose
time to maximum plasma concentration (tmax)
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 1 Aug 2019.
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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.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@Lundbeck.com
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 Vortioxetine IV, Vortioxetine SLA and Vortioxetine SLB in people with Healthy, run by H. Lundbeck A/S at 1 site in United Kingdom.
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 1 inclusion and 1 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 1 Aug 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 United Kingdom. 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?
absolute bioavailability (F) (time frame: From predose to 72 hours post dose). 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 1 Aug 2019.