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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03884491
Recruitment Status : Completed
First Posted : March 21, 2019
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

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

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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

Resource links provided by the National Library of Medicine


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




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)



Information from the National Library of Medicine

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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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884491


Locations
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United Kingdom
Quotient Sciences Ltd
Nottingham, United Kingdom
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
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Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@Lundbeck.com
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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT03884491    
Other Study ID Numbers: 18026A
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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