Pharmacokinetic Properties of Vortioxetine in Healthy Young Chinese Men and Women
A Randomised, Open-label, Single-centre, Single- and Multiple-dose Interventional Study Investigating the Pharmacokinetic Properties of Vortioxetine in Healthy Young Chinese Men and Women
1 other identifier
interventional
64
1 country
1
Brief Summary
The purpose of this study is to determine the pharmacokinetic (PK) parameters of vortioxetine after single and multiple oral dosing to healthy Chinese men and women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2015
Shorter than P25 for phase_1
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 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 5, 2015
CompletedFirst Posted
Study publicly available on registry
March 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedMay 19, 2015
May 1, 2015
2 months
March 5, 2015
May 18, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Pharmacokinetics (PK) of vortioxetine and its metabolites: Cmax, AUC, t1/2, oral clearance, apparent volume of distribution, accumulation index, metabolic ratio
Composite pharmacokinetic outcome measures (PK parameters: Cmax, AUC, t1/2, oral clearance, apparent volume of distribution, accumulation index, metabolic ratio)
Day 1 to 312 hours post-dose
Study Arms (4)
Vortioxetine 10 mg single dose
EXPERIMENTAL8 men and 8 women
Vortioxetine 20 mg single dose
EXPERIMENTAL8 men and 8 women
Vortioxetine 10 mg multiple dose
EXPERIMENTAL8 men and 8 women
Vortioxetine 20 mg multiple dose
EXPERIMENTAL8 men and 8 women
Interventions
10 mg tablet for oral use, single dose
Two 10 mg tablets for oral use, single dose,
10 mg tablet for oral use once, daily for 14 days.
Two 10 mg tablets for oral use, once daily for 14 days.
Eligibility Criteria
You may qualify if:
- Healthy young Chinese men or women
- Between 18 and 45 years of age (extremes included)
- BMI between 18.5 and 24 kg/m2 (extremes included)
- Body weight ≥45 kg.
You may not qualify if:
- Pregnant or lactating.
- Previously been dosed with vortioxetine
- The subject has taken any investigational medicinal products within 3 months prior to the first dose of IMP (investigational medicinal product)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lundbeck A/Slead
Study Sites (1)
CB801
Chengdu, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Email contact via H. Lundbeck A/S
LundbeckClinicalTrials@lundbeck.com
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2015
First Posted
March 12, 2015
Study Start
March 1, 2015
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
May 19, 2015
Record last verified: 2015-05