PK, Safety and Tolerability of Sublingual Vortioxetine (QSC200369)
Research type
Research Study
Full title
Interventional, open-label, sequential-period study investigating the pharmacokinetic properties and safety and tolerability of sublingual formulations of vortioxetine in healthy subjects
IRAS ID
256285
Contact name
Dorrit Østergaard Nilausen
Contact email
Sponsor organisation
H. Lundbeck A/S
Eudract number
2018-002246-37
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 29 days
Research summary
The Sponsor is developing a new sublingual (under the tongue) form of the test medicine, vortioxetine, for the potential treatment of Major Depressive Disorder (MDD).
MDD, also known as depression, is a mental disorder that effects people's mood. It causes severe symptoms that affect how people feel, think, and handle daily activities, such as sleeping, eating, or working. It is often accompanied by a loss of interest in normally enjoyable activities, low energy and pain that cannot be explained.
The study will compare how well the test medicine is taken up by the body when given sublingually compared to when it is administered intravenously (directly into the vein).
The study will consist of 5 study periods involving up to 16 healthy male and female volunteers. Each Period, volunteers will receive a single dose of the test medicine. In Period 1 the test medicine will be given as a slow injection into the vein and volunteers will remain in the clinical unit for 144 hours after dosing. In Periods 2 to 5 the test medicine will be given under the tongue and volunteers will remain in the clinical unit for 72 hours after dosing.
REC name
Wales REC 2
REC reference
19/WA/0044
Date of REC Opinion
14 Feb 2019
REC opinion
Favourable Opinion