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Completed

NCT Number: NCT02386488

Pharmacokinetic Properties of Vortioxetine in Healthy Young Chinese Men and Women

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.

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Key information

Conditions

Pharmacokinetics

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CB801

Chengdu, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)

Other protocol defined inclusion and exclusion criteria may apply

Treatment and study plan

Vortioxetine 10 mg single dose

Drug

10 mg tablet for oral use, single dose

Other names: Lu AA21004

Vortioxetine 20 mg single dose

Drug

Two 10 mg tablets for oral use, single dose,

Other names: Lu AA21004

Vortioxetine 10 mg multiple dose

Drug

10 mg tablet for oral use once, daily for 14 days.

Other names: Lu AA21004

Vortioxetine 20 mg multiple dose

Drug

Two 10 mg tablets for oral use, once daily for 14 days.

Other names: Lu AA21004

Primary outcomes

  1. Pharmacokinetics (PK) of vortioxetine and its metabolites: Cmax, AUC, t1/2, oral clearance, apparent volume of distribution, accumulation index, metabolic ratio

    Time frame: Day 1 to 312 hours post-dose

    Composite pharmacokinetic outcome measures (PK parameters: Cmax, AUC, t1/2, oral clearance, apparent volume of distribution, accumulation index, metabolic ratio)

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 12, 2015
Registry last updated
May 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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