BioequivalencePhase 1NCT02894515
Bioequivalence Study of Idalopirdine in Healthy Subjects
A Phase 1 study testing Idalopirdine commercial tablet (test) and Idalopirdine clinical tablet (reference) in people with Bioequivalence, run by H. Lundbeck A/S at 1 site in United Kingdom.
Trial summary
The purpose of this study is to investigate whether 2 different tablet compositions are similar regarding absorption (uptake) in the body. One composition was used in the clinical development program and the other is intended for the market Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Idalopirdine commercial tablet (test) and Idalopirdine clinical tablet (reference)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2016to Sep 2016
- 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 with a body mass index (BMI) of >18.5 and <30 kg/m2.
Who cannot join
- pregnant or lactating women
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 10 mg Commercial Tablet (Test) to the 10 mg Clinical Tablet (Reference)
The purpose of this study is to investigate whether 2 different tablet compositions are similar regarding absorption (uptake) in the body. One composition was used in the clinical development program and the other is intended for the market
- Conditions
- Bioequivalence
- Being tested
- Idalopirdine commercial tablet (test), Idalopirdine clinical tablet (reference)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Idalopirdine commercial tablet (test)Drug
single dose, 10 mg, oral
Idalopirdine clinical tablet (reference)Drug
single dose, 10 mg, oral
| Study group | Role | What they receive |
|---|---|---|
| Test/Reference | Experimental | Single dose of commercial tablet Treatment A (Test) in period I. Followed by single dose of clinical tablet Treatment B (Reference) in period II. First and second dose administration will be separated by a washout period of at least 7 days Receives: Drug: Idalopirdine commercial tablet (test); Drug: Idalopirdine clinical tablet (reference) |
| Reference/Test | Experimental | Single dose of clinical tablet Treatment B (Reference) in period I. Followed by single dose of commercial tablet Treatment A (Test) in period II. First and second dose administration will be separated by a washout period of at least 7 days Receives: Drug: Idalopirdine commercial tablet (test); Drug: Idalopirdine clinical tablet (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 (AUC0-t) from time zero to the last quantifiable concentration post-dose
Measured: baseline to 72 hours post-dose
Maximum observed concentration of idalopirdine (Cmax)
Measured: baseline to 72 hours post-dose
Secondary outcomes (3)
Time to occurrence of Cmax (tmax)
Measured: baseline to 72 hours post-dose
Area under the idalopirdine plasma concentration-time curve (AUC0-inf) from time zero to infinity
Measured: baseline to 72 hours post-dose
Apparent elimination half-life (t1/2)
Measured: baseline 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 posted9 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: The study was withdrawn based on new efficacy data from another study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies 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
- 0 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
- NCT02894515
- Sponsor's protocol ID
- 16976A
- Other IDs
- 2016-000405-37, 2016
- Status last verified
- Nov 2016
- First submitted
- 5 Sep 2016
- Last updated
- 11 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2016. 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 10 mg Commercial Tablet (Test) to the 10 mg Clinical Tablet (Reference)
- ClinicalTrials.gov ID
- NCT02894515
- Acronym / sponsor ID
- 16976A
- Conditions
- Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn based on new efficacy data from another study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 9 Sep 2016 (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 investigate whether 2 different tablet compositions are similar regarding absorption (uptake) in the body. One composition was used in the clinical development program and the other is intended for the market
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test/Reference | Experimental | Drug: Idalopirdine commercial tablet (test), Drug: Idalopirdine clinical tablet (reference)Single dose of commercial tablet Treatment A (Test) in period I. Followed by single dose of clinical tablet Treatment B (Reference) in period II. First and second dose administration will be separated by a washout period of at least 7 days |
| Reference/Test | Experimental | Drug: Idalopirdine commercial tablet (test), Drug: Idalopirdine clinical tablet (reference)Single dose of clinical tablet Treatment B (Reference) in period I. Followed by single dose of commercial tablet Treatment A (Test) in period II. First and second dose administration will be separated by a washout period of at least 7 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy men and women with a body mass index (BMI) of >18.5 and <30 kg/m2.
Key exclusion criteria (1 listed)
- pregnant or lactating women
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 commercial tablet (test)single dose, 10 mg, oral | Drug | Reference/Test, Test/Reference |
| Idalopirdine clinical tablet (reference)single dose, 10 mg, oral | Drug | Reference/Test, Test/Reference |
Primary outcome
Area under the idalopirdine plasma concentration-time curve (AUC0-t) from time zero to the last quantifiable concentration post-dose
Time frame: baseline to 72 hours post-dose
Maximum observed concentration of idalopirdine (Cmax)
Time frame: baseline to 72 hours post-dose
3 secondary outcomes
Time to occurrence of Cmax (tmax)
Time frame: baseline to 72 hours post-dose
Area under the idalopirdine plasma concentration-time curve (AUC0-inf) from time zero to infinity
Time frame: baseline to 72 hours post-dose
Apparent elimination half-life (t1/2)
Time frame: baseline to 72 hours post-dose
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2016.
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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 commercial tablet (test) and Idalopirdine clinical tablet (reference) in people with Bioequivalence, 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 11 Nov 2016. 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 was withdrawn before enrolling participants, so there are no results.
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 (AUC0-t) from time zero to the last quantifiable concentration post-dose (time frame: baseline 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 11 Nov 2016.