HealthyPhase 1NCT02371707
Bioequivalence Study of Idalopirdine Tablets 60 mg
A Phase 1 study testing Idalopirdine 60 mg formulation A (test) and Idalopirdine 60 mg formulation B (reference) in people with Healthy, run by H. Lundbeck A/S at 1 site in United Kingdom.
Trial summary
This study aims to establish bioequivalence between two tablet formulations of idalopirdine 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?
- Idalopirdine 60 mg formulation A (test) and Idalopirdine 60 mg formulation B (reference)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2015to Apr 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women
- -≥18 and ≤55 years of age
- body mass index (BMI) of >18.5 and <30 kg/m2
Who cannot join
- Pregnant and lactating women
- Other protocol defined inclusion and exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional, Randomised, Open-label, Two-way Crossover, Single-dose Bioequivalence Study of Idalopirdine in Healthy Subjects Comparing the 60 mg Commercial Tablet (Test) to the 60 mg Clinical Tablet (Reference)
This study aims to establish bioequivalence between two tablet formulations of idalopirdine
- Conditions
- Healthy
- Being tested
- Idalopirdine 60 mg formulation A (test), Idalopirdine 60 mg formulation B (reference)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Idalopirdine 60 mg formulation A (test)Drug
Also called Lu AE58054
Tablet for oral use, single dose
Idalopirdine 60 mg formulation B (reference)Drug
Also called Lu AE58054
Tablet for oral use, single dose
| Study group | Role | What they receive |
|---|---|---|
| Idalopirdine 60 mg formulation A (test) | Experimental | Not described Receives: Drug: Idalopirdine 60 mg formulation A (test) |
| Idalopirdine 60 mg formulation B (reference) | Experimental | Not described Receives: Drug: Idalopirdine 60 mg formulation B (reference) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the idalopirdine plasma concentration-time curve
Measured: 0 to 72 hours post-dose
maximum observed concentration (Cmax) of idalopirdine
Measured: 0 to 72 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 posted26 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionApr 2015
- Study completionApr 2015
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
- 30 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
- NCT02371707
- Sponsor's protocol ID
- 16052A
- Other IDs
- 2014-001799-69, 2014
- Status last verified
- May 2015
- First submitted
- 20 Feb 2015
- Last updated
- 7 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Randomised, Open-label, Two-way Crossover, Single-dose Bioequivalence Study of Idalopirdine in Healthy Subjects Comparing the 60 mg Commercial Tablet (Test) to the 60 mg Clinical Tablet (Reference)
- ClinicalTrials.gov ID
- NCT02371707
- Acronym / sponsor ID
- 16052A
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 26 Feb 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.
This study aims to establish bioequivalence between two tablet formulations of idalopirdine
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Idalopirdine 60 mg formulation A (test) | Experimental | Drug: Idalopirdine 60 mg formulation A (test) |
| Idalopirdine 60 mg formulation B (reference) | Experimental | Drug: Idalopirdine 60 mg formulation B (reference) |
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
- -≥18 and ≤55 years of age
- body mass index (BMI) of >18.5 and <30 kg/m2
Key exclusion criteria (2 listed)
- Pregnant and lactating women
- 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 |
|---|---|---|
| Idalopirdine 60 mg formulation A (test)Also: Lu AE58054Tablet for oral use, single dose | Drug | Idalopirdine 60 mg formulation A (test) |
| Idalopirdine 60 mg formulation B (reference)Also: Lu AE58054Tablet for oral use, single dose | Drug | Idalopirdine 60 mg formulation B (reference) |
Primary outcome
Area under the idalopirdine plasma concentration-time curve
Time frame: 0 to 72 hours post-dose
maximum observed concentration (Cmax) of idalopirdine
Time frame: 0 to 72 hours post-dose
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 7 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 Idalopirdine 60 mg formulation A (test) and Idalopirdine 60 mg formulation B (reference) in people with Healthy, run by H. Lundbeck A/S at 1 site in United Kingdom.
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 7 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 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?
Area under the idalopirdine plasma concentration-time curve (time frame: 0 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?
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 7 May 2015.