NCT03884491

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Vortioxetine IV	an intravenous (IV) 10 mg dose (1 mg/mL) of vortioxetine infused over 2 hours
DRUG	Vortioxetine SLA	5-25 mg of sublingual formulation A of vortioxetine
DRUG	Vortioxetine SLB	5-25 mg of sublingual formulation B of vortioxetine
DRUG	Vortioxetine SLC	formulation SLC: solution of vortioxetine, concentrate (12.5 mg/mL-62,5 mg/mL) 200 uL or 400 uL, SL, 5-25 mg

Timeline

• Start date: 2019-03-18
• Primary completion: 2019-06-25
• Completion: 2019-07-22
• First posted: 2019-03-21
• Last updated: 2019-08-01

Locations

1 site across 1 country: United Kingdom