A Study Investigating Formulations of Vortioxetine Applied Under the Tongue in Healthy Subjects

Study Overview
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Brief Summary
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This study investigates formulations of vortioxetine applied under the tongue

Detailed Description
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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

Official Title
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Interventional, Open-label, Sequential-period Study Investigating the Pharmacokinetic Properties and Safety and Tolerability of Sublingual Formulations of Vortioxetine in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Vortioxetine IV
* Drug: Vortioxetine SLA
* Drug: Vortioxetine SLB
* Drug: Vortioxetine SLC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -The subject has a BMI ≥18.5 and ≤30.0 kg/m2 at the Screening Visit and at the Baseline Visit. Exclusion Criteria: -The subject is identified or confirmed to be a CYP2D6 poor metabolizer (PM)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vortioxetine<br> | Drug: Vortioxetine IV<br>* an intravenous (IV) 10 mg dose (1 mg/mL) of vortioxetine infused over 2 hours<br>Drug: Vortioxetine SLA<br>* 5-25 mg of sublingual formulation A of vortioxetine<br>Drug: Vortioxetine SLB<br>* 5-25 mg of sublingual formulation B of vortioxetine<br>Drug: Vortioxetine SLC<br>* formulation SLC: solution of vortioxetine, concentrate (12.5 mg/mL-62,5 mg/mL) 200 uL or 400 uL, SL, 5-25 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| absolute bioavailability (F) | absolute bioavailability of vortioxetine for the sublingual administrations | From predose to 72 hours post dose | 
| tmax | time to maximum plasma concentration (tmax) | From predose to 72 hours post dose |