Pharmacokinetic Properties of Vortioxetine in Healthy Young Chinese Men and Women

Pharmacokinetics Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02386488
• Other study ID #: 16060A
• Status: Completed
• Phase: Phase 1
• First received: March 5, 2015
• Last updated: May 18, 2015
• Start date: March 2015
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Drug:
• Vortioxetine 10 mg single dose
10 mg tablet for oral use, single dose
• Vortioxetine 20 mg single dose
Two 10 mg tablets for oral use, single dose,
• Vortioxetine 10 mg multiple dose
10 mg tablet for oral use once, daily for 14 days.
• Vortioxetine 20 mg multiple dose
Two 10 mg tablets for oral use, once daily for 14 days.

Locations

Country	Name	City	State
China	CB801	Chengdu

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No