Pharmacokinetic Properties of Vortioxetine in Healthy Young Chinese Men and Women

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics

Treatments: Drug: Vortioxetine 20 mg multiple dose; Drug: Vortioxetine 10 mg multiple dose; Drug: Vortioxetine 20 mg single dose; Drug: Vortioxetine 10 mg single dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT02386488

16060A

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 4 patient groups

Vortioxetine 10 mg single dose

Experimental group

Description:

8 men and 8 women

Treatment:

Drug: Vortioxetine 10 mg single dose

Vortioxetine 20 mg single dose

Experimental group

Description:

8 men and 8 women

Treatment:

Drug: Vortioxetine 20 mg single dose

Vortioxetine 10 mg multiple dose

Experimental group

Description:

8 men and 8 women

Treatment:

Drug: Vortioxetine 10 mg multiple dose

Vortioxetine 20 mg multiple dose

Experimental group

Description:

8 men and 8 women

Treatment:

Drug: Vortioxetine 20 mg multiple dose