Healthy Adult ParticipantsPhase 1NCT03437564

A Bioequivalence Study of the Lu AA21004 20 mg and 2×10 mg Tablets

A Phase 1 study testing Vortioxetine in people with Healthy Adult Participants, run by Takeda at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to evaluate the bioequivalence of a single oral administration of a vortioxetine (Lu AA21004) 20 mg tablet in comparison with two of vortioxetine 10 mg tablets in Japanese healthy adult participants. Read more about this study

Who is it for?: Ages 20 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Adult Participants
What is being tested?: Vortioxetine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteJapan
Study dates: 16 Feb 2018to 13 Apr 2018
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Be a healthy Japanese adult volunteer.
Understand the contents of the study and is capable of providing written consent to participate in the study.
Be willing to comply with all study procedures and restrictions.
Aged between ≥20 and ≤45 years at the time of screening.
Have a BMI of ≥18.5 and ≤24.9 (kg/m^2) and a body weight of ≥50 kg at the time of screening.
Be a extensive metabolizer (EM) based on CYP2D6 genotyping at the time of screening.
A female participant of childbearing potential with a non-sterilized male partner must agree to routinely use appropriate contraception during the study from the time of signing informed consent until 4 weeks after last dosing of the study drug.

Who cannot join

Has received any investigational drug within 90 days before screening for this study.
Previously received Lu AA21004 before participation in this study.
Is an employee of the sponsor or the study site, or immediate family member, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or who may be coerced to provide consent.
Has uncontrolled, clinically relevant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality which may affect study participation or study results.
Has a history of multiple episodes or severe allergies (eg, food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerance to prescription drugs, over the counter (OTC) drugs, or foods.
Has a positive pregnancy test at the time of screening or Day -1.

Show all 22Show fewer

Is a pregnant or lactating female.
Has a positive urine drug screen test at the time of screening or Day -1.
Has a history of drug abuse (defined as any illicit drug use) or has a history of alcohol dependence within 2 years before the start of screening or is unwilling to agree to abstain from alcohol and drugs throughout the study.
Consumes 6 or more servings of caffeinated beverages (containing about 120 mg of caffeine per serving) such as of coffee, tea, cola, or energy drinks.
Is a smoker who smoked cigarettes or used nicotine-containing products (such as nicotine patch) within 6 months before the Period 1 study drug administration.
Used any of the excluded drugs, dietary products or foods during the specified time periods, or will need any of them during the study period.
Has any current or recent gastrointestinal diseases that would be expected to influence the absorption of drugs (ie, a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent [more than once per week] occurrence of heartburn), or any surgical intervention (Stomach, cholecystectomy etc.).
Has a history of cancer.
Has a positive test result for any of the following at the time of screening: hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody/antigen, serological test for syphilis.
Has poor peripheral venous access.
Has undergone whole blood collection of at least 200 mL within 4 weeks (28 days) or at least 400 mL within 12 weeks (84 days) prior to the start of Period 1 study drug administration.
Has undergone whole blood collection of at least 800 mL in total within 52 weeks (364 days) prior to the start of Period 1 study drug administration.
Has undergone blood component collection within 2 weeks (14 days) prior to the start of Period 1 study drug administration.
Has any clinically relevant abnormality in vital signs or 12-lead electrocardiograms (ECG) at screening or on Day -1 of Period 1.
Has abnormal laboratory test values at screening or on Day -1 of Period 1 indicating clinically relevant underlying disease, or showing alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >1.5×upper limit of normal (ULN).
Is unlikely to comply with the protocol requirements or is unsuitable as a participant of this study for any other reason in the opinion of the investigator or sub-investigator.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Nishi Kumamoto Hospital
Kumamoto

Other trials in Japan

About this study

Official title: A Randomized, Open-Label, 2×2 Crossover Phase 1 Study to Evaluate the Bioequivalence of Single Oral Dose of Lu AA21004 20 mg Tablet and 2× Lu AA21004 10 mg Tablets in Healthy Adult Subjects

Read the detailed description

The drug being tested in this study is called vortioxetine (Lu AA21004). Vortioxetine is being tested in Japanese healthy adult participants. This study will look at the bioequivalence of a single oral administration of a vortioxetine 20 mg tablet in comparison with two of vortioxetine 10 mg tablets, and also look at the safety of a single oral dose of vortioxetine 20 mg in Japanese healthy adult participants.

The study will enroll 28 (14 for each sequence) healthy participants. In case bioequivalence cannot be demonstrated with the number of participants initially planned, an add-on participant study may be conducted (as a maximum 28 participants additionally). Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups.

Treatment Group A: Vortioxetine 20 mg (one 20 mg tablet) in Period 1 + Vortioxetine 20 mg (two 10 mg tablets) in Period 2
Treatment Group B: Vortioxetine 20 mg (two 10 mg tablets) in Period 1 + Vortioxetine 20 mg (one 20 mg tablet) in Period 2

This single-center trial will be conducted in Japan. The overall time to participate in this study is approximately 25 days. Participants will make two visits to the clinic and be hospitalized for ten days in total.

Conditions: Healthy Adult Participants
Being tested: Vortioxetine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VortioxetineDrug
Also called Lu AA21004
Vortioxetine tablet

Study groups in NCT03437564
Study group	Role	What they receive
Vortioxetine one 20 mg tablet + two 10 mg tablets	Experimental	Vortioxetine 20 mg (one 20 mg tablet) on Day 1 in Period 1 in a fasted state + vortioxetine 20 mg (two 10 mg tablets) on Day 1 in Period 2 in a fasted state. Receives: Drug: Vortioxetine
Vortioxetine two 10 mg tablets + one 20 mg tablet	Experimental	Vortioxetine 20 mg (two 10 mg tablets) on Day 1 in Period 1 in a fasted state + vortioxetine 20 mg (one 20 mg tablet) on Day 1 in Period 2 in a fasted state. Receives: Drug: Vortioxetine

What is being measured

The primary outcome is the main question the study is designed to answer.

AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Time Point of Unchanged Lu AA21004
Measured: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Cmax: Maximum Plasma Concentration (Observed Value) of Unchanged Lu AA21004
Measured: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

Secondary outcomes (10)

AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of Unchanged Lu AA21004
Measured: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Tmax: Time to Reach Cmax (Observed Value) of Unchanged Lu AA21004
Measured: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
MRT∞, ev: Mean Residence Time 0 to Infinity of Unchanged Lu AA21004
Measured: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
MRTlast, ev: Mean Residence Time From Time 0 to the Time of the Last Quantifiable Concentration of Unchanged Lu AA21004
Measured: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
λz: Apparent Elimination Rate Constant of Unchanged Lu AA21004
Measured: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
T1/2z: Apparent Elimination Half-Life of Unchanged Lu AA21004
Measured: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)
Measured: Up to Day 25
Number of Participants With TEAE Related to Vital Sign
Measured: Up to Day 25
Number of Participants With TEAE Related to Clinical Laboratory Tests (Alanine Aminotransferase Increased)
Measured: Up to Day 25
Number of Participants With TEAE Related to 12-lead Electrocardiograms
Measured: Up to Day 25

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Feb 201813 Apr 2018

First posted19 Feb 2018
Study start16 Feb 2018
Primary completion13 Apr 2018
Study completion13 Apr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
More trials run by TakedaThe 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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03437564
Sponsor's protocol ID: Vortioxetine-1001
Other IDs: U1111-1208-2715, JapicCTI-183863
Status last verified: Jun 2019
First submitted: 13 Feb 2018
Last updated: 27 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-Label, 2×2 Crossover Phase 1 Study to Evaluate the Bioequivalence of Single Oral Dose of Lu AA21004 20 mg Tablet and 2× Lu AA21004 10 mg Tablets in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT03437564
Acronym / sponsor ID: Vortioxetine-1001
Conditions: Healthy Adult Participants
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 16 Feb 2018 (actual)
Primary completion: 13 Apr 2018 (actual)
Study completion: 13 Apr 2018 (actual)
First posted: 19 Feb 2018 (actual)
Results: Posted 26 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Treatment Group A: Vortioxetine 20 mg (one 20 mg tablet) in Period 1 + Vortioxetine 20 mg (two 10 mg tablets) in Period 2
Treatment Group B: Vortioxetine 20 mg (two 10 mg tablets) in Period 1 + Vortioxetine 20 mg (one 20 mg tablet) in Period 2

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Vortioxetine one 20 mg tablet + two 10 mg tablets	Experimental	Drug: VortioxetineVortioxetine 20 mg (one 20 mg tablet) on Day 1 in Period 1 in a fasted state + vortioxetine 20 mg (two 10 mg tablets) on Day 1 in Period 2 in a fasted state.
Vortioxetine two 10 mg tablets + one 20 mg tablet	Experimental	Drug: VortioxetineVortioxetine 20 mg (two 10 mg tablets) on Day 1 in Period 1 in a fasted state + vortioxetine 20 mg (one 20 mg tablet) on Day 1 in Period 2 in a fasted state.

Who may qualify

Ages: 20 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Be a healthy Japanese adult volunteer.
Understand the contents of the study and is capable of providing written consent to participate in the study.
Be willing to comply with all study procedures and restrictions.
Aged between ≥20 and ≤45 years at the time of screening.
Have a BMI of ≥18.5 and ≤24.9 (kg/m^2) and a body weight of ≥50 kg at the time of screening.

Key exclusion criteria (22 listed)

Has received any investigational drug within 90 days before screening for this study.
Previously received Lu AA21004 before participation in this study.
Is an employee of the sponsor or the study site, or immediate family member, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or who may be coerced to provide consent.
Has uncontrolled, clinically relevant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality which may affect study participation or study results.
Has a history of multiple episodes or severe allergies (eg, food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerance to prescription drugs, over the counter (OTC) drugs, or foods.

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
VortioxetineAlso: Lu AA21004Vortioxetine tablet	Drug	Vortioxetine one 20 mg tablet + two 10 mg tablets, Vortioxetine two 10 mg tablets + one 20 mg tablet

Primary outcome

AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Time Point of Unchanged Lu AA21004
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Cmax: Maximum Plasma Concentration (Observed Value) of Unchanged Lu AA21004
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

10 secondary outcomes

AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of Unchanged Lu AA21004
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Tmax: Time to Reach Cmax (Observed Value) of Unchanged Lu AA21004
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
MRT∞, ev: Mean Residence Time 0 to Infinity of Unchanged Lu AA21004
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
MRTlast, ev: Mean Residence Time From Time 0 to the Time of the Last Quantifiable Concentration of Unchanged Lu AA21004
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
λz: Apparent Elimination Rate Constant of Unchanged Lu AA21004
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
T1/2z: Apparent Elimination Half-Life of Unchanged Lu AA21004
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)
Time frame: Up to Day 25
Number of Participants With TEAE Related to Vital Sign
Time frame: Up to Day 25
Number of Participants With TEAE Related to Clinical Laboratory Tests (Alanine Aminotransferase Increased)
Time frame: Up to Day 25
Number of Participants With TEAE Related to 12-lead Electrocardiograms
Time frame: Up to Day 25

Results and safety

Results posted to the registry on 26 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vortioxetine One 20 mg Tablet + Two 10 mg Tablets	14	14
Vortioxetine Two 10 mg Tablets + One 20 mg Tablet	14	14

Primary outcome: AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Time Point of Unchanged Lu AA21004

Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose. Mean (Standard Deviation). Unit: hour*nanogram per milliliter (h*ng/mL)

Measure	Vortioxetine One 20 mg Tablet n = 28	Vortioxetine Two 10 mg Tablets n = 28
Value	299.3 (59.820)	301.1 (62.070)

Vortioxetine One 20 mg Tablet vs Vortioxetine Two 10 mg Tablets: Point Estimate: 0.996 (90% CI 0.967 to 1.026), ANOVA

Population analysed: Pharmacokinetic (PK) Analysis Set; PK analysis set included all treated participants who had no major protocol violations, completed the minimum element of the protocol, and had evaluable pharmacokinetic data.

Primary outcome: Cmax: Maximum Plasma Concentration (Observed Value) of Unchanged Lu AA21004

Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose. Mean (Standard Deviation). Unit: ng/mL

Measure	Vortioxetine One 20 mg Tablet n = 28	Vortioxetine Two 10 mg Tablets n = 28
Value	8.744 (1.7838)	8.976 (1.6936)

Vortioxetine One 20 mg Tablet vs Vortioxetine Two 10 mg Tablets: Point Estimate: 0.972 (90% CI 0.937 to 1.008), ANOVA

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Day 25. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vortioxetine One 20 mg Tablet	0 of 28 (0%)	1 of 28 (3.6%)	0 of 28
Vortioxetine Two 10 mg Tablets	0 of 28 (0%)	0 of 28 (0%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

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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.

Study Director study director

Takeda

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 in people with Healthy Adult Participants, run by Takeda at 1 site in Japan.

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 7 inclusion and 22 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 27 Jun 2019. 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 Japan. 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?

Yes. Results are posted in the registry (first posted 26 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Time Point of Unchanged Lu AA21004 (time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose). 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 NCT03437564.

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 27 Jun 2019.