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

Interventional, open-label, sequential-period study investigating the pharmacokinetic properties and safety and tolerability of sublingual formulations of vortioxetine in healthy subjects - PK, Safety and Tolerability of Sublingual Vortioxetine (QSC200369)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002246-37-GB

Enrollment

Registered

2019-10-24

Start date

2019-03-13

Completion date

Unknown

Last updated

2020-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder (MDD), also known as depression MedDRA version: 21.1 Level: LLT Classification code 10081270 Term: Major depressive disorder System Organ Class: 100000004873

Interventions

Product Name: Vortioxetine – 1 mg/mL concentrate for solution for infusion Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Vortioxetine hydrobromide Current Sponsor cod

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The subject has a BMI =18.5 and =30.0 kg/m2 at the Screening Visit and at the Baseline Visit Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 16 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 16

Exclusion criteria

Exclusion criteria: The subject is identified or confirmed to be a CYP2D6 poor metabolizer (PM)

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): Pharmacokinetic endpoints: - area under the plasma concentration-time curve from time zero to infinity (AUC0-inf). t½ will only be estimated for Period 1 and will be used for the estimation of AUC0-inf for the other periods. - area under the plasma concentration-time curve from time zero to 72 hours post dose (AUC0-72) - maximum observed concentration (Cmax) - apparent elimination half-life (Period 1 only) - clearance (CL, Period 1 only) - volume of distribution (Vz, Period 1 only) • Safety endpoints: - adverse events - absolute values and changes from baseline in clinical safety laboratory test values, vital signs, weight, and ECG assessments - potentially clinically significant (PCS) clinical safety laboratory test values, vital signs, weight changes, and irritation of oral cavity - ECG assessments • Exploratory endpoint: - Palatability parameters scored on a Visual Analogue Scale (Periods 2 to 5 only);Timepoint(s) of evaluation of this end point: Various timepoints throughout the study, as per the protocol.	—

Measure

Time frame

Secondary end point(s): Pharmacokinetic endpoints: - area under the plasma concentration-time curve from time zero to infinity (AUC0-inf). t½ will only be estimated for Period 1 and will be used for the estimation of AUC0-inf for the other periods. - area under the plasma concentration-time curve from time zero to 72 hours post dose (AUC0-72) - maximum observed concentration (Cmax) - apparent elimination half-life (Period 1 only) - clearance (CL, Period 1 only) - volume of distribution (Vz, Period 1 only) • Safety endpoints: - adverse events - absolute values and changes from baseline in clinical safety laboratory test values, vital signs, weight, and ECG assessments - potentially clinically significant (PCS) clinical safety laboratory test values, vital signs, weight changes, and irritation of oral cavity - ECG assessments • Exploratory endpoint: - Palatability parameters scored on a Visual Analogue Scale (Periods 2 to 5 only);Timepoint(s) of evaluation of this end point: Various timepoints throughout the study, as per the protocol.

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Primary

Measure	Time frame
Main Objective: This study investigates formulations of vortioxetine applied under the tongue;Secondary Objective: Safety: to evaluate the safety and tolerability of the different vortioxetine formulations Exploratory: to explore the palatability (taste) of the sublingual formulations ;Primary end point(s): 1. absolute bioavailability (F) absolute bioavailability of vortioxetine for the sublingual administrations [Time Frame: From predose to 72 hours post dose] 2. tmax time to maximum plasma concentration (tmax) [Time Frame: From predose to 72 hours post dose];Timepoint(s) of evaluation of this end point: Various timepoints throughout the study, as per the protocol.	—

Measure

Time frame

Main Objective: This study investigates formulations of vortioxetine applied under the tongue;Secondary Objective: Safety: to evaluate the safety and tolerability of the different vortioxetine formulations Exploratory: to explore the palatability (taste) of the sublingual formulations ;Primary end point(s): 1. absolute bioavailability (F) absolute bioavailability of vortioxetine for the sublingual administrations [Time Frame: From predose to 72 hours post dose] 2. tmax time to maximum plasma concentration (tmax) [Time Frame: From predose to 72 hours post dose];Timepoint(s) of evaluation of this end point: Various timepoints throughout the study, as per the protocol.

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Countries

United Kingdom

Contacts

Public ContactDorrit Østergaard Nilausen

H. Lundbeck A/S

DOE@lundbeck.com+45 30 83 2925

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026