Qt Interval, Variation inPhase 1NCT02924337
Effect of Imeglimin on QT/QTc Intervals in Healthy Subjects
A Phase 1 study testing Imeglimin and Moxifloxacin in people with Qt Interval, Variation in, run by Poxel SA at 1 site in United Kingdom.
Trial summary
The purpose of this study is to assess the effect of a single therapeutic dose and a single supra-therapeutic dose of imeglimin on the QT/QTc interval Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Qt Interval, Variation in
- What is being tested?
- Imeglimin and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2016to Dec 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteers
- BMI between 18.5 and 29.9 kg/m2
- weighing between 55 and 95 kg
- willing to use reliable contraception
- able to give fully informed written consent.
Who cannot join
- Pregnant or lactating woman, or sexually active woman of child-bearing potential not using highly effective contraception
- clinically relevant abnormal medical history, surgery or concurrent medical condition; acute or chronic illness
- clinically significant QT/QTc interval prolongation at Baseline
- history of drug-induced or risk factors for Torsade de Pointes
- any contraindication to moxifloxacin
- severe adverse reaction to any drug or sensitivity to the trial medication or its components
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- significant food allergy; use of vitamins, herbal medicines, prescription or over-the-counter medication (with the exception of paracetamol [acetaminophen] and oral contraceptives for women) within 20 days or 6 half-lives before first dose of trial medication
- participation in other clinical trials of unlicensed or prescription medicines, or loss of more than 400 mL blood, within the 3 months before first dose of trial medication
- drug or alcohol abuse; smoking of more than 5 cigarettes, 1 cigars or 1 pipes daily
- regular consumption of more than 5 cups of caffeinated drinks per day
- positive test for hepatitis A, B \& C, HIV
- objection by a General Practitioner.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Placebo and Active Controlled Crossover Study to Assess the Effect of Single Dose Administration of 2 Doses of Imeglimin on QT/QTc Intervals in Healthy Subjects
The purpose of this study is to assess the effect of a single therapeutic dose and a single supra-therapeutic dose of imeglimin on the QT/QTc interval
- Conditions
- Qt Interval, Variation in
- Being tested
- Placebo, Imeglimin, Moxifloxacin
- Keywords
- QT/QTC interval, Hypoglycemic Agents, Imeglimin, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
ImegliminDrug
MoxifloxacinDrug
| Study group | Role | What they receive |
|---|---|---|
| Imeglimin therapeutic dose | Experimental | Tablet, oral, single dose Receives: Drug: Imeglimin |
| Imeglimin supratherapeutic dose | Experimental | Tablet, oral, single dose Receives: Drug: Imeglimin |
| Placebo | Placebo comparator | Tablet, oral, single dose Receives: Drug: Placebo |
| Moxifloxacin | Active comparator | Tablet, oral, single dose (400 mg) Receives: Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in QTcF (deltaQTcF)
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Qt Interval, Variation inStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poxel SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julie Dubourg, MD, Study director, Poxel SAPascale Fouqueray, MD, PhD, Study director, Poxel SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02924337
- Sponsor's protocol ID
- PXL008-016
- Other IDs
- 2016-001821-14, 2016
- Status last verified
- Feb 2017
- First submitted
- 4 Oct 2016
- Last updated
- 10 Feb 2017
- Results posted
- No
Publications
Dubourg J, Perrimond-Dauchy S, Felices M, Bolze S, Voiriot P, Fouqueray P. Absence of QTc prolongation in a thorough QT study with imeglimin, a first in class oral agent for type 2 diabetes mellitus. Eur J Clin Pharmacol. 2020 Oct;76(10):1393-1400. doi: 10.1007/s00228-020-02929-6. Epub 2020 Jun 18.
PubMed 32556539
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo and Active Controlled Crossover Study to Assess the Effect of Single Dose Administration of 2 Doses of Imeglimin on QT/QTc Intervals in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02924337
- Acronym / sponsor ID
- PXL008-016
- Conditions
- Qt Interval, Variation in
- Keywords
- QT/QTC interval, Hypoglycemic Agents, Imeglimin, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Poxel SAIndustry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 5 Oct 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 assess the effect of a single therapeutic dose and a single supra-therapeutic dose of imeglimin on the QT/QTc interval
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Imeglimin therapeutic dose | Experimental | Drug: ImegliminTablet, oral, single dose |
| Imeglimin supratherapeutic dose | Experimental | Drug: ImegliminTablet, oral, single dose |
| Placebo | Placebo comparator | Drug: PlaceboTablet, oral, single dose |
| Moxifloxacin | Active comparator | Drug: MoxifloxacinTablet, oral, single dose (400 mg) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- healthy volunteers
- BMI between 18.5 and 29.9 kg/m2
- weighing between 55 and 95 kg
- willing to use reliable contraception
- able to give fully informed written consent.
Key exclusion criteria (12 listed)
- Pregnant or lactating woman, or sexually active woman of child-bearing potential not using highly effective contraception
- clinically relevant abnormal medical history, surgery or concurrent medical condition; acute or chronic illness
- clinically significant QT/QTc interval prolongation at Baseline
- history of drug-induced or risk factors for Torsade de Pointes
- any contraindication to moxifloxacin
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 |
|---|---|---|
| Placebo | Drug | Placebo |
| Imeglimin | Drug | Imeglimin supratherapeutic dose, Imeglimin therapeutic dose |
| Moxifloxacin | Drug | Moxifloxacin |
Primary outcome
Change from baseline in QTcF (deltaQTcF)
Time frame: Up to 24 hours
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 10 Feb 2017.
- Derived from this study: PubMed 32556539Dubourg J, Perrimond-Dauchy S, Felices M, Bolze S, Voiriot P, Fouqueray P. Absence of QTc prolongation in a thorough QT study with imeglimin, a first in class oral agent for type 2 diabetes mellitus. Eur J Clin Pharmacol. 2020 Oct;76(10):1393-1400. doi: 10.1007/s00228-020-02929-6. Epub 2020 Jun 18.
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.
Julie Dubourg, MD study director
Poxel SA
Pascale Fouqueray, MD, PhD study director
Poxel SA
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 Imeglimin and Moxifloxacin in people with Qt Interval, Variation in, run by Poxel SA 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 5 inclusion and 12 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 10 Feb 2017. 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. 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 baseline in QTcF (deltaQTcF) (time frame: Up to 24 hours). 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 NCT02924337, which also lists 1 linked publication.
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 10 Feb 2017.