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

NCT ID: NCT03884491

Last Updated: 2019-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-18
• Study Completion Date: 2019-07-22

Brief 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

Study Design

• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vortioxetine

Group Type: EXPERIMENTAL

Vortioxetine IV

Intervention Type: DRUG

an intravenous (IV) 10 mg dose (1 mg/mL) of vortioxetine infused over 2 hours

Vortioxetine SLA

Intervention Type: DRUG

5-25 mg of sublingual formulation A of vortioxetine

Vortioxetine SLB

Intervention Type: DRUG

5-25 mg of sublingual formulation B of vortioxetine

Vortioxetine SLC

Intervention Type: DRUG

formulation SLC: solution of vortioxetine, concentrate (12.5 mg/mL-62,5 mg/mL) 200 uL or 400 uL, SL, 5-25 mg

Interventions

Vortioxetine IV

an intravenous (IV) 10 mg dose (1 mg/mL) of vortioxetine infused over 2 hours

Intervention Type: DRUG

Vortioxetine SLA

5-25 mg of sublingual formulation A of vortioxetine

Intervention Type: DRUG

Vortioxetine SLB

5-25 mg of sublingual formulation B of vortioxetine

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@Lundbeck.com

Locations

Quotient Sciences Ltd

Nottingham, , United Kingdom

Countries

United Kingdom

Other Identifiers

18026A

Identifier Type: -

Identifier Source: org_study_id