Pharmacokinetic Properties of Vortioxetine in Healthy Young Chinese Men and Women

May 18, 2015 updated by: H. Lundbeck A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Chengdu, China
        • CB801

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Vortioxetine 10 mg single dose
8 men and 8 women
Drug: Vortioxetine 10 mg single dose
10 mg tablet for oral use, single dose
Other Names:
  • Lu AA21004
EXPERIMENTAL: Vortioxetine 20 mg single dose
8 men and 8 women
Drug: Vortioxetine 20 mg single dose
Two 10 mg tablets for oral use, single dose,
Other Names:
  • Lu AA21004
EXPERIMENTAL: Vortioxetine 10 mg multiple dose
8 men and 8 women
Drug: Vortioxetine 10 mg multiple dose
10 mg tablet for oral use once, daily for 14 days.
Other Names:
  • Lu AA21004
EXPERIMENTAL: Vortioxetine 20 mg multiple dose
8 men and 8 women
Drug: Vortioxetine 20 mg multiple dose
Two 10 mg tablets for oral use, once daily for 14 days.
Other Names:
  • Lu AA21004

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Day 1 to 312 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lundbeck A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (ACTUAL)

May 1, 2015

Study Completion (ACTUAL)

May 1, 2015

Study Registration Dates

First Submitted

March 5, 2015

First Submitted That Met QC Criteria

March 11, 2015

First Posted (ESTIMATE)

March 12, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

May 19, 2015

Last Update Submitted That Met QC Criteria

May 18, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16060A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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