HealthyPhase 1NCT01676571
Pharmacokinetic Properties of Lu AA21004 (Vortioxetine) in Healthy Young Chinese Men and Women
A Phase 1 study testing Lu AA21004 in people with Healthy, run by H. Lundbeck A/S at 1 site in China.
Trial summary
The rationale for this pharmacokinetic (PK) study is to determine the PK parameters for Lu AA21004 (Vortioxetine) in the Chinese population. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lu AA21004
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- Oct 2012to Nov 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
The rationale for this pharmacokinetic (PK) study is to determine the PK parameters for Lu AA21004 (Vortioxetine) in the Chinese population.
- Conditions
- Healthy
- Being tested
- Lu AA21004
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AA21004Drug
Also called Vortioxetine
10 mg immediate-release (IR), one single dose, orally
| Study group | Role | What they receive |
|---|---|---|
| Lu AA21004 | Experimental | Not described Receives: Drug: Lu AA21004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK AUC determination of Lu AA21004 (Vortioxetine)
Area under the curve (AUC)
Measured: 11 days
PK Cmax determination of Lu AA21004 (Vortioxetine)
Maximum observed concentration (Cmax)
Measured: 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2012 (estimated)
- Study startOct 2012
- Primary completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01676571
- Sponsor's protocol ID
- 14077A
- Status last verified
- Jan 2013
- First submitted
- 29 Aug 2012
- Last updated
- 16 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31552551
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01676571
- Acronym / sponsor ID
- 14077A
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Nov 2012 (actual)
- First posted
- 31 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The rationale for this pharmacokinetic (PK) study is to determine the PK parameters for Lu AA21004 (Vortioxetine) in the Chinese population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lu AA21004 | Experimental | Drug: Lu AA21004 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lu AA21004Also: Vortioxetine10 mg immediate-release (IR), one single dose, orally | Drug | Lu AA21004 |
Primary outcome
PK AUC determination of Lu AA21004 (Vortioxetine)
Time frame: 11 days
Area under the curve (AUC)
PK Cmax determination of Lu AA21004 (Vortioxetine)
Time frame: 11 days
Maximum observed concentration (Cmax)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2013.
- Derived from this study: PubMed 31552551Miao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@lundbeck.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lu AA21004 in people with Healthy, run by H. Lundbeck A/S at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK AUC determination of Lu AA21004 (Vortioxetine) (time frame: 11 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01676571, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2013.