Healthy VolunteersPhase 1NCT02436486
Study Investigating the Effect of Idalopirdine on Cardiac Repolarisation in Healthy Men
A Phase 1 study testing ldalopirdine 120 mg, Idalopirdine 360 mg and Moxifloxacin 400 mg in people with Healthy Volunteers, run by H. Lundbeck A/S at 1 site in France.
Trial summary
To evaluate the effect of idalopirdine (120 and 360 mg) on cardiac repolarisation in healthy men. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ldalopirdine 120 mg, Idalopirdine 360 mg and Moxifloxacin 400 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteFrance
- Study dates
- May 2015to Aug 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body weight at least 50 kg and Body Mass index >18.5 and < 30 kg/m2
- Good general health ascertained by a detailed medical history, laboratory tests and physical examination
- Use of contraception.
Who cannot join
- The subject has evidence of cardiac conduction abnormalities as calculated by the ECG equipment and evaluated by the investigator, at the Screening Visit or at the Baseline visit
- The subject has a history of long QT syndrome, history of cardiac arrhythmia, or history of cardiac disease (eg, coronary artery disease, valvular disease, etc.).
- Other protocol defined inclusion and exclusion criteria do apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional, Randomised, Double-blind, Placebo- and Positive Controlled, Single-dose, Cross-over Study Investigating the Effect of Idalopirdine on Cardiac Repolarisation in Healthy Men
To evaluate the effect of idalopirdine (120 and 360 mg) on cardiac repolarisation in healthy men.
- Conditions
- Healthy Volunteers
- Being tested
- Placebo, ldalopirdine 120 mg, Idalopirdine 360 mg, Moxifloxacin 400 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Capsules, orally, single dose
ldalopirdine 120 mgDrug
Two 60 mg encapsulated film-coated tablets, orally, single dose
Idalopirdine 360 mgDrug
Four 90 mg encapsulated film-coated tablets, orally, single dose
Moxifloxacin 400 mgDrug
Encapsulated tablets, orally, single dose
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Idalopirdine 120 mg | Experimental | Therapeutic dosages Receives: Drug: ldalopirdine 120 mg |
| Idalopirdine 360 mg | Experimental | Supra-therapeutic dosages Receives: Drug: Idalopirdine 360 mg |
| Moxifloxacin 400 mg | Active comparator | Positive Control Receives: Drug: Moxifloxacin 400 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from pre-dose baseline in the QT interval (ΔQTcF) at each post-dose time point within the ECG collection period
The QT interval will be corrected for heart rate by using the Fridericia's method (QTcF)
Measured: For 24 hours in each dosing period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startMay 2015
- Primary completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 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
- NCT02436486
- Sponsor's protocol ID
- 15689A
- Other IDs
- 2013-002387-12
- Status last verified
- Sep 2015
- First submitted
- 4 May 2015
- Last updated
- 22 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Randomised, Double-blind, Placebo- and Positive Controlled, Single-dose, Cross-over Study Investigating the Effect of Idalopirdine on Cardiac Repolarisation in Healthy Men
- ClinicalTrials.gov ID
- NCT02436486
- Acronym / sponsor ID
- 15689A
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Aug 2015 (actual)
- First posted
- 6 May 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.
To evaluate the effect of idalopirdine (120 and 360 mg) on cardiac repolarisation in healthy men.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Idalopirdine 120 mg | Experimental | Drug: ldalopirdine 120 mgTherapeutic dosages |
| Idalopirdine 360 mg | Experimental | Drug: Idalopirdine 360 mgSupra-therapeutic dosages |
| Moxifloxacin 400 mg | Active comparator | Drug: Moxifloxacin 400 mgPositive Control |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body weight at least 50 kg and Body Mass index >18.5 and < 30 kg/m2
- Good general health ascertained by a detailed medical history, laboratory tests and physical examination
- Use of contraception.
Key exclusion criteria (3 listed)
- The subject has evidence of cardiac conduction abnormalities as calculated by the ECG equipment and evaluated by the investigator, at the Screening Visit or at the Baseline visit
- The subject has a history of long QT syndrome, history of cardiac arrhythmia, or history of cardiac disease (eg, coronary artery disease, valvular disease, etc.).
- Other protocol defined inclusion and exclusion criteria do 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 |
|---|---|---|
| PlaceboCapsules, orally, single dose | Drug | Placebo |
| ldalopirdine 120 mgTwo 60 mg encapsulated film-coated tablets, orally, single dose | Drug | Idalopirdine 120 mg |
| Idalopirdine 360 mgFour 90 mg encapsulated film-coated tablets, orally, single dose | Drug | Idalopirdine 360 mg |
| Moxifloxacin 400 mgEncapsulated tablets, orally, single dose | Drug | Moxifloxacin 400 mg |
Primary outcome
Change from pre-dose baseline in the QT interval (ΔQTcF) at each post-dose time point within the ECG collection period
Time frame: For 24 hours in each dosing period
The QT interval will be corrected for heart rate by using the Fridericia's method (QTcF)
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 22 Sep 2015.
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Screening Protocol
Pain
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 ldalopirdine 120 mg, Idalopirdine 360 mg and Moxifloxacin 400 mg in people with Healthy Volunteers, run by H. Lundbeck A/S at 1 site in France.
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 3 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 22 Sep 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 France. 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. Some participants in this study may receive a placebo. 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?
Change from pre-dose baseline in the QT interval (ΔQTcF) at each post-dose time point within the ECG collection period (time frame: For 24 hours in each dosing period). 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 22 Sep 2015.