Cardiology: RR / QTPhase 1iQTESTNCT01338441
Selections of Subjects With Important Changes in Their Cardiac Repolarization Parameters for the Procurement of Skin and Blood Samples
A Phase 1 study testing Erythromycin in people with Cardiology: RR / QT, run by Ectycell SASU at 1 site in France.
Trial summary
The study main objective is to assess the changes in the ventricular repolarization (measure by the delta QTcf) after drug induced stimulation, compare to placebo, in order to identify subjects with extreme responses and collecting their skin and blood samples. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiology: RR / QT
- What is being tested?
- Erythromycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2011to Aug 2011
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 40 years of age
- Caucasian origin
- BMI 19 to 29 kg/m²
- Informed Consent obtained
- National Health Security Number
- Eligible for Phase I as mentioned in the national registry of healthy volunteers
Show all 28Show fewer
- For woman: use of an effective contraceptive method
- Non Inclusion Criteria:
- Asthma
- Heart Rate < 50 bpm
- Hypotension with systolic blood pressure< 100 mm Hg.
- atrioventricular block (PR interval > 200 ms)
- Known Chronic illness (hepatic, renal or cardiac impairment, etc..)
- Raynaud's phenomenon
- Drug known to prolong QT (http://www.azcert.org/medical-pros/drug-lists/drug-lists.cfm) in the last 7 days.
- All chronic treatments are forbidden exceptive : oral contraceptives, paracetamol, vitamins and comfort treatment that do not prolong the QT
- Known family or individual past history of QT prolongation or unexplained syncope
- (QTcF) > 450 ms
- QRS interval non assessable on ECG at rest or bundle-branch block, QRS > 100 ms
- Allergy to macrolide type antibiotics
- Known allergy to sotalol or lidocaine
- Positive blood pregnancy test (Inclusion visit)
- Known abnormal haemostasis
- Kaliemia< 3.5 mmol/L
- Magnesemia< 0,7 mmol/L
- Under exclusion period or participating to another clinical trial on a new medicinal product
- Creatinin clearance < 80 ml/min (Cockroft and Gault formula)
- AST-ALT >3x upper normal limit
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Selections of Subjects With Dramatic Changes in Their Cardiac Repolarization Parameters After a Pharmacologic Stimulus Aiming to Collect Their Skin Biopsy and Blood Cells
The study main objective is to assess the changes in the ventricular repolarization (measure by the delta QTcf) after drug induced stimulation, compare to placebo, in order to identify subjects with extreme responses and collecting their skin and blood samples.
Read the detailed description
An ECG is performed after a dose of sotalol on about 100 healthy subjects in order to identify about 20 extreme responders (10 high responders and 10 non responders) assessed as Delta QTcf compare to baseline. The ECG will be measured and the delta QTcf will be calculated on the 20 selected subjects in a second part of the clinical trial, cross over erythromycin/placebo.
- Conditions
- Cardiology: RR / QT
- Being tested
- Erythromycin, Placebo
- Keywords
- Drug induced QT prolongation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErythromycinDrug
4mg/Kg, IV during 20 min once
PlaceboDrug
4mg/Kg, IV during 20 min once
| Study group | Role | What they receive |
|---|---|---|
| Erythromycin | Experimental | Not described Receives: Drug: Erythromycin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolongation of cardiac QT due to erythromycin compare to Placebo reported as Delta QTcf
Delta QTcf is measured at H0, H0+20 minutes, and H0+1h20, on groups' erythromycin and placebo. QTcf may be adjusted based on the pharmacokinetic data to ensure time of the plasmatic pick is used.
Measured: 1hour and 20 minutes
Secondary outcomes (2)
Comparison Delta QTcf eryhtromycin-sotalol
compare the effect of erythromycin and sotalol on QT prologation
Measured: over 3 hours
Assess the effect of erythromycin Twave morphologie changes
Analysis of Qwave morphologic changes
Measured: 1hour and 20 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2011
- Study completionAug 2011
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 Cardiology: RR / QTStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ectycell SASU
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pierre and Marie Curie University, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
- Investigators
- Jean Sebastien Hulot, MD, Study director, University PMCurrie-INSERM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01338441
- Sponsor's protocol ID
- 2010-022000-41
- Acronym
- iQTEST
- Status last verified
- Sep 2011
- First submitted
- 15 Apr 2011
- Last updated
- 15 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stillitano F, Hansen J, Kong CW, Karakikes I, Funck-Brentano C, Geng L, Scott S, Reynier S, Wu M, Valogne Y, Desseaux C, Salem JE, Jeziorowska D, Zahr N, Li R, Iyengar R, Hajjar RJ, Hulot JS. Modeling susceptibility to drug-induced long QT with a panel of subject-specific induced pluripotent stem cells. Elife. 2017 Jan 30;6:e19406. doi: 10.7554/eLife.19406.
PubMed 28134617
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selections of Subjects With Dramatic Changes in Their Cardiac Repolarization Parameters After a Pharmacologic Stimulus Aiming to Collect Their Skin Biopsy and Blood Cells
- ClinicalTrials.gov ID
- NCT01338441
- Acronym / sponsor ID
- iQTEST / 2010-022000-41
- Conditions
- Cardiology: RR / QT
- Keywords
- Drug induced QT prolongation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Ectycell SASUIndustry (pharma, biotech, devices)
- Collaborators
- Pierre and Marie Curie University, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Mar 2011
- Primary completion
- May 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 19 Apr 2011 (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 study main objective is to assess the changes in the ventricular repolarization (measure by the delta QTcf) after drug induced stimulation, compare to placebo, in order to identify subjects with extreme responses and collecting their skin and blood samples.
Detailed description
An ECG is performed after a dose of sotalol on about 100 healthy subjects in order to identify about 20 extreme responders (10 high responders and 10 non responders) assessed as Delta QTcf compare to baseline. The ECG will be measured and the delta QTcf will be calculated on the 20 selected subjects in a second part of the clinical trial, cross over erythromycin/placebo.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erythromycin | Experimental | Drug: Erythromycin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (28 listed)
- 18 to 40 years of age
- Caucasian origin
- BMI 19 to 29 kg/m²
- Informed Consent obtained
- National Health Security Number
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Erythromycin4mg/Kg, IV during 20 min once | Drug | Erythromycin |
| Placebo4mg/Kg, IV during 20 min once | Drug | Placebo |
Primary outcome
Prolongation of cardiac QT due to erythromycin compare to Placebo reported as Delta QTcf
Time frame: 1hour and 20 minutes
Delta QTcf is measured at H0, H0+20 minutes, and H0+1h20, on groups' erythromycin and placebo. QTcf may be adjusted based on the pharmacokinetic data to ensure time of the plasmatic pick is used.
2 secondary outcomes
Comparison Delta QTcf eryhtromycin-sotalol
Time frame: over 3 hours
Assess the effect of erythromycin Twave morphologie changes
Time frame: 1hour and 20 min
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 15 Sep 2011.
- Derived from this study: PubMed 28134617Stillitano F, Hansen J, Kong CW, Karakikes I, Funck-Brentano C, Geng L, Scott S, Reynier S, Wu M, Valogne Y, Desseaux C, Salem JE, Jeziorowska D, Zahr N, Li R, Iyengar R, Hajjar RJ, Hulot JS. Modeling susceptibility to drug-induced long QT with a panel of subject-specific induced pluripotent stem cells. Elife. 2017 Jan 30;6:e19406. doi: 10.7554/eLife.19406.
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.
Jean Sebastien Hulot, MD study director
University PMCurrie-INSERM
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 Erythromycin in people with Cardiology: RR / QT, run by Ectycell SASU 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 28 inclusion and 0 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 15 Sep 2011. 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?
Prolongation of cardiac QT due to erythromycin compare to Placebo reported as Delta QTcf (time frame: 1hour and 20 minutes). 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 NCT01338441, 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 15 Sep 2011.