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
• Sponsor: H. Lundbeck A/S
• Information provided by (Responsible Party): H. Lundbeck A/S

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 (Clinical Trial)
• 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: March 18, 2019
• Actual Primary Completion Date: June 25, 2019
• Actual Study Completion Date: July 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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

United Kingdom

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

More Information

• Responsible Party: H. Lundbeck A/S
• ClinicalTrials.gov Identifier: NCT03884491
• Other Study ID Numbers: 18026A
• First Posted: March 21, 2019
• Last Update Posted: August 1, 2019
• Last Verified: July 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Vortioxetine; Antidepressive Agents; Psychotropic Drugs; Anti-Anxiety Agents; Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Serotonin Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT3 Receptor Antagonists; Serotonin Antagonists