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

Healthy Clinical Trial

Official title:

Interventional, Open-label, Sequential-period Study Investigating the Pharmacokinetic Properties and Safety and Tolerability of Sublingual Formulations of Vortioxetine in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03884491
• Other study ID #: 18026A
• Status: Completed
• Phase: Phase 1
• Start date: March 18, 2019
• Est. completion date: July 22, 2019

Study information

• Verified date: July 2019
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study investigates formulations of vortioxetine applied under the tongue

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 22, 2019
• Est. primary completion date: June 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Vortioxetine IV
an intravenous (IV) 10 mg dose (1 mg/mL) of vortioxetine infused over 2 hours
• Vortioxetine SLA
5-25 mg of sublingual formulation A of vortioxetine
• Vortioxetine SLB
5-25 mg of sublingual formulation B of vortioxetine
• 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

Locations

Country	Name	City	State
United Kingdom	Quotient Sciences Ltd	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	absolute bioavailability (F)	absolute bioavailability of vortioxetine for the sublingual administrations	From predose to 72 hours post dose
Primary	tmax	time to maximum plasma concentration (tmax)	From predose to 72 hours post dose