Pharmacokinetic Properties of Lu AA21004 (Vortioxetine) in Healthy Young Chinese Men and Women

This study has been completed.
Information provided by (Responsible Party):
H. Lundbeck A/S Identifier:
First received: August 29, 2012
Last updated: January 15, 2013
Last verified: January 2013
The rationale for this pharmacokinetic (PK) study is to determine the PK parameters for Lu AA21004 (Vortioxetine) in the Chinese population.

Condition Intervention Phase
Drug: Lu AA21004
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single-centre, Open-label, Single-dose Interventional Study Investigating the Pharmacokinetic Properties of Lu AA21004 in Healthy Young Chinese Men and Women

Resource links provided by NLM:

Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • PK AUC determination of Lu AA21004 (Vortioxetine) [ Time Frame: 11 days ] [ Designated as safety issue: No ]
    Area under the curve (AUC)

  • PK Cmax determination of Lu AA21004 (Vortioxetine) [ Time Frame: 11 days ] [ Designated as safety issue: No ]
    Maximum observed concentration (Cmax)

Other Outcome Measures:
  • PK MR determination of metabolites Lu AA34443 and Lu AA39835 [ Time Frame: 11 days ] [ Designated as safety issue: No ]
    Metabolic ratio (MR)

  • Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: 11 days ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: October 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lu AA21004 Drug: Lu AA21004
10 mg immediate-release (IR), one single dose, orally
Other Name: Vortioxetine


Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • The subject is a Chinese man or woman
  • The subject is, in the opinion of the investigator, generally healthy
  • If female, the subject must have a negative pregnancy test at screening and baseline, and agree not to try to become pregnant from Screening until after the Follow-up Visit

Exclusion Criteria:

  • The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason.

Other inclusion and exclusion criteria may apply.

  Contacts and Locations
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Please refer to this study by its identifier: NCT01676571

Tianjin, China, 300457
Sponsors and Collaborators
H. Lundbeck A/S
Study Director: Email contact via H. Lundbeck A/S
  More Information

Responsible Party: H. Lundbeck A/S Identifier: NCT01676571     History of Changes
Other Study ID Numbers: 14077A 
Study First Received: August 29, 2012
Last Updated: January 15, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Anti-Anxiety Agents
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin 5-HT1 Receptor Agonists
Serotonin 5-HT1 Receptor Antagonists
Serotonin 5-HT3 Receptor Antagonists
Serotonin Agents
Serotonin Antagonists
Serotonin Receptor Agonists
Serotonin Uptake Inhibitors
Therapeutic Uses
Tranquilizing Agents processed this record on April 27, 2016