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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT01676571
First received: August 29, 2012
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

The rationale for this pharmacokinetic (PK) study is to determine the PK parameters for Lu AA21004 (Vortioxetine) in the Chinese population.


Condition Intervention Phase
Healthy
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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01676571

Locations
China
CN001
Tianjin, China, 300457
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
  More Information

No publications provided

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on April 22, 2014