A Study Investigating Formulations of Vortioxetine Applied Under the Tongue in Healthy Subjects
|ClinicalTrials.gov Identifier: NCT03884491|
Recruitment Status : Completed
First Posted : March 21, 2019
Last Update Posted : August 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Vortioxetine IV Drug: Vortioxetine SLA Drug: Vortioxetine SLB Drug: Vortioxetine SLC||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Interventional, Open-label, Sequential-period Study Investigating the Pharmacokinetic Properties and Safety and Tolerability of Sublingual Formulations of Vortioxetine in Healthy Subjects|
|Actual Study Start Date :||March 18, 2019|
|Actual Primary Completion Date :||June 25, 2019|
|Actual Study Completion Date :||July 22, 2019|
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
- 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884491
|Quotient Sciences Ltd|
|Nottingham, United Kingdom|
|Study Director:||Email contact via H. Lundbeck A/S||LundbeckClinicalTrials@Lundbeck.com|