PharmacokineticsPhase 1NCT02386488
Pharmacokinetic Properties of Vortioxetine in Healthy Young Chinese Men and Women
A Phase 1 study testing Vortioxetine 10 mg single dose, Vortioxetine 20 mg single dose and Vortioxetine 10 mg multiple dose in people with Pharmacokinetics, run by H. Lundbeck A/S at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Vortioxetine 10 mg single dose, Vortioxetine 20 mg single dose and Vortioxetine 10 mg multiple dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to May 2015
- 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
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Open-label, Single-centre, Single- and Multiple-dose Interventional Study Investigating the Pharmacokinetic Properties of Vortioxetine in Healthy Young Chinese Men and Women
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.
- Conditions
- Pharmacokinetics
- Being tested
- Vortioxetine 10 mg single dose, Vortioxetine 20 mg single dose, Vortioxetine 10 mg multiple dose, Vortioxetine 20 mg multiple dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vortioxetine 10 mg single doseDrug
Also called Lu AA21004
10 mg tablet for oral use, single dose
Vortioxetine 20 mg single doseDrug
Also called Lu AA21004
Two 10 mg tablets for oral use, single dose,
Vortioxetine 10 mg multiple doseDrug
Also called Lu AA21004
10 mg tablet for oral use once, daily for 14 days.
Vortioxetine 20 mg multiple doseDrug
Also called Lu AA21004
Two 10 mg tablets for oral use, once daily for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Vortioxetine 10 mg single dose | Experimental | 8 men and 8 women Receives: Drug: Vortioxetine 10 mg single dose |
| Vortioxetine 20 mg single dose | Experimental | 8 men and 8 women Receives: Drug: Vortioxetine 20 mg single dose |
| Vortioxetine 10 mg multiple dose | Experimental | 8 men and 8 women Receives: Drug: Vortioxetine 10 mg multiple dose |
| Vortioxetine 20 mg multiple dose | Experimental | 8 men and 8 women Receives: Drug: Vortioxetine 20 mg multiple dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) of vortioxetine and its metabolites: Cmax, AUC, t1/2, oral clearance, apparent volume of distribution, accumulation index, metabolic ratio
Composite pharmacokinetic outcome measures (PK parameters: Cmax, AUC, t1/2, oral clearance, apparent volume of distribution, accumulation index, metabolic ratio)
Measured: Day 1 to 312 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 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
- NCT02386488
- Sponsor's protocol ID
- 16060A
- Status last verified
- May 2015
- First submitted
- 5 Mar 2015
- Last updated
- 19 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Open-label, Single-centre, Single- and Multiple-dose Interventional Study Investigating the Pharmacokinetic Properties of Vortioxetine in Healthy Young Chinese Men and Women
- ClinicalTrials.gov ID
- NCT02386488
- Acronym / sponsor ID
- 16060A
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 12 Mar 2015 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vortioxetine 10 mg single dose | Experimental | Drug: Vortioxetine 10 mg single dose8 men and 8 women |
| Vortioxetine 20 mg single dose | Experimental | Drug: Vortioxetine 20 mg single dose8 men and 8 women |
| Vortioxetine 10 mg multiple dose | Experimental | Drug: Vortioxetine 10 mg multiple dose8 men and 8 women |
| Vortioxetine 20 mg multiple dose | Experimental | Drug: Vortioxetine 20 mg multiple dose8 men and 8 women |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Vortioxetine 10 mg single doseAlso: Lu AA2100410 mg tablet for oral use, single dose | Drug | Vortioxetine 10 mg single dose |
| Vortioxetine 20 mg single doseAlso: Lu AA21004Two 10 mg tablets for oral use, single dose, | Drug | Vortioxetine 20 mg single dose |
| Vortioxetine 10 mg multiple doseAlso: Lu AA2100410 mg tablet for oral use once, daily for 14 days. | Drug | Vortioxetine 10 mg multiple dose |
| Vortioxetine 20 mg multiple doseAlso: Lu AA21004Two 10 mg tablets for oral use, once daily for 14 days. | Drug | Vortioxetine 20 mg multiple dose |
Primary outcome
Pharmacokinetics (PK) of vortioxetine and its metabolites: Cmax, AUC, t1/2, oral clearance, apparent volume of distribution, accumulation index, metabolic ratio
Time frame: Day 1 to 312 hours post-dose
Composite pharmacokinetic outcome measures (PK parameters: Cmax, AUC, t1/2, oral clearance, apparent volume of distribution, accumulation index, metabolic ratio)
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 19 May 2015.
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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 Vortioxetine 10 mg single dose, Vortioxetine 20 mg single dose and Vortioxetine 10 mg multiple dose in people with Pharmacokinetics, 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 4 inclusion and 4 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 19 May 2015. 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?
Pharmacokinetics (PK) of vortioxetine and its metabolites: Cmax, AUC, t1/2, oral clearance, apparent volume of distribution, accumulation index, metabolic ratio (time frame: Day 1 to 312 hours post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2015.