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

Sponsor

H. Lundbeck A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT03884491

Collaborator

(none)

Enrollment

Location

Arm

4.1

Actual Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study investigates formulations of vortioxetine applied under the tongue

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Vortioxetine IV Drug: Vortioxetine SLA Drug: Vortioxetine SLB Drug: Vortioxetine SLC	Phase 1

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

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 :

Mar 18, 2019

Actual Primary Completion Date :

Jun 25, 2019

Actual Study Completion Date :

Jul 22, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vortioxetine	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

Arm

Intervention/Treatment

Experimental: Vortioxetine

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

Outcome Measures

Primary Outcome Measures

absolute bioavailability (F) [From predose to 72 hours post dose]
absolute bioavailability of vortioxetine for the sublingual administrations
tmax [From predose to 72 hours post dose]
time to maximum plasma concentration (tmax)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Quotient Sciences Ltd	Nottingham		United Kingdom

Sponsors and Collaborators

H. Lundbeck A/S

Investigators

Study Director: Email contact via H. Lundbeck A/S, LundbeckClinicalTrials@Lundbeck.com

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

H. Lundbeck A/S

ClinicalTrials.gov Identifier:

NCT03884491

Other Study ID Numbers:

18026A

First Posted:

Mar 21, 2019

Last Update Posted:

Aug 1, 2019

Last Verified:

Jul 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Vortioxetine

Study Results

No Results Posted as of Aug 1, 2019