A Study Investigating Formulations of Vortioxetine Applied Under the Tongue in Healthy Subjects
Interventional, Open-label, Sequential-period Study Investigating the Pharmacokinetic Properties and Safety and Tolerability of Sublingual Formulations of Vortioxetine in Healthy Subjects
1 other identifier
interventional
16
1 country
1
Brief Summary
This study investigates formulations of vortioxetine applied under the tongue
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Mar 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 18, 2019
CompletedFirst Submitted
Initial submission to the registry
March 19, 2019
CompletedFirst Posted
Study publicly available on registry
March 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 22, 2019
CompletedAugust 1, 2019
July 1, 2019
3 months
March 19, 2019
July 30, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
absolute bioavailability (F)
absolute bioavailability of vortioxetine for the sublingual administrations
From predose to 72 hours post dose
tmax
time to maximum plasma concentration (tmax)
From predose to 72 hours post dose
Study Arms (1)
Vortioxetine
EXPERIMENTALInterventions
an intravenous (IV) 10 mg dose (1 mg/mL) of vortioxetine infused over 2 hours
formulation SLC: solution of vortioxetine, concentrate (12.5 mg/mL-62,5 mg/mL) 200 uL or 400 uL, SL, 5-25 mg
Eligibility Criteria
You may qualify if:
- The subject has a BMI ≥18.5 and ≤30.0 kg/m2 at the Screening Visit and at the Baseline Visit.
You may not qualify if:
- The subject is identified or confirmed to be a CYP2D6 poor metabolizer (PM)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lundbeck A/Slead
Study Sites (1)
Quotient Sciences Ltd
Nottingham, United Kingdom
Study Officials
- STUDY DIRECTOR
Email contact via H. Lundbeck A/S
LundbeckClinicalTrials@Lundbeck.com
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2019
First Posted
March 21, 2019
Study Start
March 18, 2019
Primary Completion
June 25, 2019
Study Completion
July 22, 2019
Last Updated
August 1, 2019
Record last verified: 2019-07