HealthyPhase 1NCT03394482

Bioequivalence Study of Lu AF35700

A Phase 1 study testing Lu AF35700 5 mg clinical formulation, Lu AF35700 5 mg commercial formulation and Lu AF35700 10 mg clinical formulation in people with Healthy, run by H. Lundbeck A/S at 1 site in United Kingdom.

Completed

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

Official record

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Trial summary

The purpose of this study is to establish bioequivalence of Lu AF35700 between the clinical formulation and the commercial formulation for three tablet strengths; 5, 10 and 20 mg Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Lu AF35700 5 mg clinical formulation, Lu AF35700 5 mg commercial formulation and Lu AF35700 10 mg clinical formulation
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 87 participants
Where: 1 siteUnited Kingdom
Study dates: 3 Jan 2018to 5 Oct 2018
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy men and women aged ≥18 and ≤55 years
Body Mass Index (BMI) of ≥18.5 and ≤32 kg/m2
Subject must be in good general health as assessed using medical history, clinical laboratory tests, and physical examination

Who cannot join

The subject must not be of childbearing potential (if a woman) or should use contraception, be surgically sterilized or not be sexually active (both sexes). Women must not be pregnant or lactating
The subject must not be a CYP2D6 or a CYP2C19 poor metaboliser
The subject has previously been dosed with Lu AF35700
Other protocol defined inclusion and exclusion criteria may apply

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Covance
Leeds

Other trials in United Kingdom

About this study

Official title: Interventional, Randomized, Open-label, Three-group, Two-sequence Crossover, Single-dose, Bioequivalence Study of Lu AF35700 in Healthy Subjects Comparing the 5, 10 and 20 mg Commercial Tablet (Test) to the 5, 10 and 20 mg Clinical Tablet (Reference)

The purpose of this study is to establish bioequivalence of Lu AF35700 between the clinical formulation and the commercial formulation for three tablet strengths; 5, 10 and 20 mg

Conditions: Healthy
Being tested: Lu AF35700 5 mg clinical formulation, Lu AF35700 5 mg commercial formulation, Lu AF35700 10 mg clinical formulation, Lu AF35700 10 mg commercial formulation, Lu AF35700 20 mg clinical formulation

What participants receive

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

Lu AF35700 5 mg clinical formulationDrug
Lu AF35700 tablets 5 mg oral single dose
Lu AF35700 5 mg commercial formulationDrug
Lu AF35700 tablets 5 mg oral single dose
Lu AF35700 10 mg clinical formulationDrug
Lu AF35700 tablets 10 mg oral single dose
Lu AF35700 10 mg commercial formulationDrug
Lu AF35700 tablets 10 mg oral single dose
Lu AF35700 20 mg clinical formulationDrug
Lu AF35700 tablets 20 mg oral single dose
Lu AF35700 20 mg commercial formulationDrug
Lu AF35700 tablets 20 mg oral single dose

Study groups in NCT03394482
Study group	Role	What they receive
Lu AF35700 5 mg clinical formulation	Experimental	Not described Receives: Drug: Lu AF35700 5 mg clinical formulation
Lu AF35700 5 mg commercial formulation	Experimental	Not described Receives: Drug: Lu AF35700 5 mg commercial formulation
Lu AF35700 10 mg clinical formulation	Experimental	Not described Receives: Drug: Lu AF35700 10 mg clinical formulation
Lu AF35700 10 mg commercial formulation	Experimental	Not described Receives: Drug: Lu AF35700 10 mg commercial formulation
Lu AF35700 20 mg clinical formulation	Experimental	Not described Receives: Drug: Lu AF35700 20 mg clinical formulation
Lu AF35700 20 mg commercial formulation	Experimental	Not described Receives: Drug: Lu AF35700 20 mg commercial formulation

What is being measured

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

AUC0-72h of Lu AF35700
Area under the Lu AF35700 plasma concentration-time curve from zero to 72 hours post-dose (AUC0-72h)
Measured: zero to 72 hours
Cmax of Lu AF35700
Maximum observed plasma concentration (Cmax) of Lu AF35700
Measured: zero to 72 hours

Secondary outcomes (2)

Tmax of Lu AF35700
Time to occurance of Cmax of Lu AF35700
Measured: zero to 72 hours
AUC0-t of Lu AF35700
Area under the Lu AF35700 concentration-time curve from zero to time of the last quantifiable plasma concentration
Measured: zero to time of the last quantifiable plasma concentration

Timeline

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

3 Jan 20185 Oct 2018

First posted9 Jan 2018
Study start3 Jan 2018
Primary completion5 Oct 2018
Study completion5 Oct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 87 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03394482
Sponsor's protocol ID: 17481A
Other IDs: 2017-001335-39, 2017
Status last verified: Nov 2018
First submitted: 3 Jan 2018
Last updated: 29 Nov 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

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 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Interventional, Randomized, Open-label, Three-group, Two-sequence Crossover, Single-dose, Bioequivalence Study of Lu AF35700 in Healthy Subjects Comparing the 5, 10 and 20 mg Commercial Tablet (Test) to the 5, 10 and 20 mg Clinical Tablet (Reference)
ClinicalTrials.gov ID: NCT03394482
Acronym / sponsor ID: 17481A
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 87 participants (actual)
Lead sponsor: H. Lundbeck A/SIndustry (pharma, biotech, devices)
Study start: 3 Jan 2018 (actual)
Primary completion: 5 Oct 2018 (actual)
Study completion: 5 Oct 2018 (actual)
First posted: 9 Jan 2018 (actual)
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 establish bioequivalence of Lu AF35700 between the clinical formulation and the commercial formulation for three tablet strengths; 5, 10 and 20 mg

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Lu AF35700 5 mg clinical formulation	Experimental	Drug: Lu AF35700 5 mg clinical formulation
Lu AF35700 5 mg commercial formulation	Experimental	Drug: Lu AF35700 5 mg commercial formulation
Lu AF35700 10 mg clinical formulation	Experimental	Drug: Lu AF35700 10 mg clinical formulation
Lu AF35700 10 mg commercial formulation	Experimental	Drug: Lu AF35700 10 mg commercial formulation
Lu AF35700 20 mg clinical formulation	Experimental	Drug: Lu AF35700 20 mg clinical formulation
Lu AF35700 20 mg commercial formulation	Experimental	Drug: Lu AF35700 20 mg commercial formulation

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Healthy men and women aged ≥18 and ≤55 years
Body Mass Index (BMI) of ≥18.5 and ≤32 kg/m2
Subject must be in good general health as assessed using medical history, clinical laboratory tests, and physical examination

Key exclusion criteria (4 listed)

The subject must not be of childbearing potential (if a woman) or should use contraception, be surgically sterilized or not be sexually active (both sexes). Women must not be pregnant or lactating
The subject must not be a CYP2D6 or a CYP2C19 poor metaboliser
The subject has previously been dosed with Lu AF35700
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
Lu AF35700 5 mg clinical formulationLu AF35700 tablets 5 mg oral single dose	Drug	Lu AF35700 5 mg clinical formulation
Lu AF35700 5 mg commercial formulationLu AF35700 tablets 5 mg oral single dose	Drug	Lu AF35700 5 mg commercial formulation
Lu AF35700 10 mg clinical formulationLu AF35700 tablets 10 mg oral single dose	Drug	Lu AF35700 10 mg clinical formulation
Lu AF35700 10 mg commercial formulationLu AF35700 tablets 10 mg oral single dose	Drug	Lu AF35700 10 mg commercial formulation
Lu AF35700 20 mg clinical formulationLu AF35700 tablets 20 mg oral single dose	Drug	Lu AF35700 20 mg clinical formulation
Lu AF35700 20 mg commercial formulationLu AF35700 tablets 20 mg oral single dose	Drug	Lu AF35700 20 mg commercial formulation

Primary outcome

AUC0-72h of Lu AF35700
Time frame: zero to 72 hours
Area under the Lu AF35700 plasma concentration-time curve from zero to 72 hours post-dose (AUC0-72h)
Cmax of Lu AF35700
Time frame: zero to 72 hours
Maximum observed plasma concentration (Cmax) of Lu AF35700

2 secondary outcomes

Tmax of Lu AF35700
Time frame: zero to 72 hours
AUC0-t of Lu AF35700
Time frame: zero to time of the last quantifiable plasma concentration

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 29 Nov 2018.

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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?

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 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 29 Nov 2018. 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 United Kingdom. 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?

AUC0-72h of Lu AF35700 (time frame: zero to 72 hours). 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 NCT03394482.

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 29 Nov 2018.