NCT01676571

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

1 month

First QC Date

August 29, 2012

Last Update Submit

January 15, 2013

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • PK AUC determination of Lu AA21004 (Vortioxetine)

    Area under the curve (AUC)

    11 days

  • PK Cmax determination of Lu AA21004 (Vortioxetine)

    Maximum observed concentration (Cmax)

    11 days

Other Outcomes (2)

  • PK MR determination of metabolites Lu AA34443 and Lu AA39835

    11 days

  • Number of patients with adverse events as a measure of safety and tolerability

    11 days

Study Arms (1)

Lu AA21004

EXPERIMENTAL
Drug: Lu AA21004

Interventions

Lu AA21004DRUG

10 mg immediate-release (IR), one single dose, orally

Also known as: Vortioxetine
Lu AA21004

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CN001

Tianjin, 300457, China

Location

Related Publications (1)

  • Miao J, Wang G, Hou J, Areberg J, Zhao Y, Hojer AM, Ettrup A. Pharmacokinetics and Safety of Vortioxetine in the Chinese Population. Adv Ther. 2019 Nov;36(11):3134-3146. doi: 10.1007/s12325-019-01092-4. Epub 2019 Sep 24.

    PMID: 31552551DERIVED

MeSH Terms

Interventions

Vortioxetine

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@lundbeck.com

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2012

First Posted

August 31, 2012

Study Start

October 1, 2012

Primary Completion

November 1, 2012

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

CN(1)