Malaria, FalciparumPhase 1NCT01103830

Safety Study on the Effect of Eurartesim™ on QT/QTc Interval Compared to Riamet in Healthy Volunteers

A Phase 1 study testing Eurartesim™ and Riamet® in people with Malaria, Falciparum, run by sigma-tau i.f.r. S.p.A. at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of such a study is to evaluate the impact of a therapeutic dose of Eurartesim™ compared to Riamet®, after multiple dose administration for 3 days in healthy male and female subjects on electrocardiographic parameters. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Malaria, Falciparum
What is being tested?: Eurartesim™ and Riamet®
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 287 participants
Where: 1 siteFrance
Study dates: Feb 2010to Dec 2010
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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male or female Caucasian subject ≥ 18 and ≤ 50 years;
Good general health (by medical history and physical examination);
For male and female subjects of childbearing potential use a double contraception method;
For female subjects of childbearing potential only: negative plasma pregnancy test at Screening and at admission in the clinical unit;
Body mass index (BMI) ≥18 and ≤ 27 kg/m2;
No clinically relevant abnormalities in blood pressure and heart rate;

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No clinically relevant abnormalities in 12-lead ECG results;
No clinically relevant abnormalities in results of laboratory tests;
Registered with the French Social Security in agreement with the French law on biomedical experimentation.

Who cannot join

A predictable poor compliance or inability to communicate well with the Investigator;
Unsuitable veins for repeated venipuncture.
Evidence of clinically relevant cardiovascular, renal, hepatic, hematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric diseases as judged by the Investigator;
A history of additional risk factors for Torsades des Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome);
The use of concomitant medications that prolong the QT/QTc interval;
Any condition requiring regular concomitant medication, including herbal products and over-the-counter (OTC) medication or predicted need of any concomitant medication during the study;

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Evidence of any clinically significant acute or chronic disease, including known or suspected HIV, hepatitis B virus (HBV) and HCV infection;
History of relevant clinical allergic reactions of any origin;
Known hypersensitivity to any of the test materials or related compounds;
Intake of any medication (except paracetamol, hormonal contraceptives and hormone replacement therapy for postmenopausal women), including OTC medications and herbal products that could affect the outcome of the study, within 2 weeks prior to the first drug administration or less than 5 times the t1/2 of that drug, whichever is the longer;
Drug abuse;
Current use of nicotine containing products and the inability to stop using nicotine containing products during confinement in the clinical centre.
Use of caffeine containing beverages exceeding 500 mg caffeine/day and the inability to refrain from the use of caffeine containing beverages during confinement in the clinical centre;
Intake of any food or any beverage containing grapefruit or grapefruit juice, orange or pomelo juice within 48 h prior to the first dosing and the inability to stop such intake during the study;
Blood donation or loss of significant amount of blood within three months prior to the first dosing;
Positive drug screen;
Positive serology to HIV (HIV1 and HIV2) and/or HCV antibodies, and/or hepatitis B surface antigen (HBsAG);
Any other condition that in the opinion of the Investigator would interfere with the evaluation of the results or constitute a health risk for the subject;
Participation in a drug study within 3 months prior to the first dosing.

Trial locations and contacts

1 site in 1 country.

France1 site

SGS aster s.a.s
Paris, 75015

Other trials in France

About this study

Official title: Phase I, Randomized, Parallel Group Study to Evaluate the Effect of Multiple Oral Doses of Eurartesim on the QT/QTc Interval Compared to Riamet, Placebo and Moxifloxacin in Healthy Male and Female Volunteers

Read the detailed description

The fight against malaria, which the WHO reactivated in 1999 with its Roll Back Malaria programme, emphasizes early curative treatment of malaria, particularly in children, in order to decrease mortality and morbidity. Recent estimates confirm a disturbing persistence of endemic malaria with around 515 million cases and 1.0 million deaths per year.The available range of standard antimalarial drugs is narrow. There are only four classes of compounds, probably with different mechanisms of action: 4-aminoquinolines, amino-alcohols, artemisinin derivatives (isolated from a plant, Artemisia annua), and antifolates and drugs related to them.

From a public health perspective, drug resistance is a critical factor that undermines malaria control.Plasmodium falciparum and resistance to chloroquine and sulfadoxine/pyrimethamine is widespread. At present, natural quinine is still effective against P. falciparum everywhere in the world except partially in South-east Asia and South America, where decreased susceptibility is reported. Only the artemisinin derivatives, used for 15 years in Asia and, more recently in Africa, have not generated clinical resistance. Overcoming or reducing resistance requires the adoption of several strategies; central to these is the use of effective chemotherapy for those who need it. In addition, to new molecules, we need to develop and implement strategies to protect drugs against resistance. Resistance to single-drug therapies will inevitably occur. Drug combinations, which have been standard practice for viral and bacterial diseases, are now being adopted for malaria as well. The artemisinin derivatives in combination with standard antimalarials are now being promoted as the best therapeutic option for treating drug-resistant malaria and retarding the development of resistance.

The aim of the present study is to investigate the effect of this new Artemisinin Combination Therapy (ACT) formulation on electrocardiographic parameters. In the literature no relevant QT prolongation associated with Piperaquine treatment has been reported in not-company sponsored trials but no specific TQT trials have been published. On the contrary it has been reported that quinine, quinidine and halofantrine induced a QT prolongation (from slight to severe).

Conditions: Malaria, Falciparum
Being tested: Eurartesim™, Riamet®, Placebo and finally Moxifloxacin
Keywords: P. falciparum Malaria, Eurartesim, ACT
Medical subject headings: Malaria, Falciparum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Eurartesim™Drug
Also called Dihydroartemisinin and Piperaquine combination therapy
3 or 4 tablets of Eurartesim™ (40mg Dihydroartemisinin and 320 mg Piperaquine phosphate), depending of body weight (3 tablets for subjects weighting less than 75 kg, 4 tablets for subjects weighting 75 kg or more), once daily from Day 1 to Day 3
Riamet®Drug
Also called artemether and lumefantrine combination therapy
4 tablets of Riamet® (20mg artemether/120mg lumefantrine) on Day -1 evening, 4 tablets of Riamet® bid (with an interval of 12 ± 0.5 h), in the morning and in the evening of Day 1 and Day 2, 4 tablets of Riamet® in the morning of Day 3.
Placebo and finally MoxifloxacinOther
Also called moxifloxacin
3 or 4 tablets of Eurartesim™ placebo, depending of body weight, (3 tablets for subjects weighting less than 75 kg, 4 tablets for subjects weighting 75 kg or more), once daily from Day1 to Day 3.
1 tablet of Izilox® (400 mg moxifloxacin) on Day 4 morning.
Eurartesim™Drug
Also called Dihydroartemisinin and Piperaquine combination therapy
3 or 4 tablets of Eurartesim™ (40mg Dihydroartemisinin and 320 mg Piperaquine phosphate), depending of body weight (3 tablets for subjects weighting less than 75 kg, 4 tablets for subjects weighting 75 kg or more), once daily from Day 1 to Day 3.
Eurartesim™Drug
Also called Dihydroartemisinin and Piperaquine combination therapy
3 or 4 tablets of Eurartesim™ (40mg Dihydroartemisinin and 320 mg Piperaquine phosphate), depending of body weight (3 tablets for subjects weighting less than 75 kg, 4 tablets for subjects weighting 75 kg or more), once daily from Day 1 to Day 3.
Placebo and finally MoxifloxacinOther
Also called moxifloxacin
3 or 4 tablets of Eurartesim™ placebo, depending of body weight, (3 tablets for subjects weighting less than 75 kg, 4 tablets for subjects weighting 75 kg or more), once daily from Day1 to Day 3.
1 tablet of Izilox® (400 mg moxifloxacin)on Day 4 morning.

Study groups in NCT01103830
Study group	Role	What they receive
Group 1	Experimental	3 or 4 tablets of Eurartesim™, depending of body weight, (3 tablets for subjects weighting less than 75 kg, 4 tablets for subjects weighting 75 kg or more), once daily from Day 1 to Day 3. Administration of Eurartesim will be in fed condition following a high-fat/low-Kcal meal. Receives: Drug: Eurartesim™
Group 2	Active comparator	4 tablets of Riamet® on Day -1 evening, 4 tablets of Riamet® bid (with an interval of 12 ± 0.5 h), in the morning and in the evening of Day 1 and Day 2, 4 tablets of Riamet® in the morning of Day 3. Administration of Riamet® will be in fed condition following a high-fat/low-Kcal meal. Receives: Drug: Riamet®
Group 3	Other	3 or 4 tablets of Eurartesim™ placebo, depending of body weight, (3 tablets for subjects weighting less than 75 kg, 4 tablets for subjects weighting 75 kg or more), once daily from Day1 to Day 3. Administration will be in the morning, in fed condition, following a high-fat/low-Kcal meal 1 tablet of Izilox® (400 mg moxifloxacin) in fed condition following a high-fat/low-Kcal meal, on Day 4 morning. Receives: Other: Placebo and finally Moxifloxacin
Group 4	Experimental	3 or 4 tablets of Eurartesim™, depending of body weight, (3 tablets for subjects weighting less than 75 kg, 4 tablets for subjects weighting 75 kg or more), once daily from Day 1 to Day 3. Administration of Eurartesim will be in fed condition following a high-fat/high-Kcal meal. Receives: Drug: Eurartesim™
Group 5	Experimental	3 or 4 tablets of Eurartesim™, depending of body weight, (3 tablets for subjects weighting less than 75 kg, 4 tablets for subjects weighting 75 kg or more), once daily from Day 1 to Day 3. Administration of Eurartesim will be in fasting condition. Receives: Drug: Eurartesim™
Group 6	Other	3 or 4 tablets of Eurartesim™ placebo, depending of body weight, (3 tablets for subjects weighting less than 75 kg, 4 tablets for subjects weighting 75 kg or more), once daily from Day1 to Day 3. Administration will be in the morning, in fasting condition. 1 tablet of Izilox® (400 mg moxifloxacin) in fed condition following a high-fat/low-Kcal meal, on Day 4 morning. Receives: Other: Placebo and finally Moxifloxacin

What is being measured

The primary outcome is the main question the study is designed to answer.

QTcF interval (Fridericia's correction QT interval)
Group 1,4 and 5 (Day -1: pre-dose, each hour till 13h post-dose. Day 1: pre-dose, 1, 2, 3, 4, 5, and 6 h post-dose. Day 3: pre-dose, each hour till 13h post-dose and then 24h).
Group 2 (Day -2: pre-dose, each hour till 13h post-dose and then 24h. Day 3: pre-dose, each hour till 13h post-dose and then 24h).
Group 3 and 6 (Day -1: pre-dose, each hour till 13h post-dose. Day 1: pre-dose, 1, 2, 3, 4, 6, 8, 12 and 24h post-dose. Day 3: pre-dose, pre-dose, each hour till 13h post-dose. Day 4: pre-dose, 1, 2, 3, 4, 6, 8, 12 and 24h post-dose).
Measured: before study drugs administration, during the 24 hrs post first and third dose and during follow-up

Secondary outcomes (5)

Effect of Eurartesim™ administered in different food conditions, on ECG parameters
To evaluate the impact of a therapeutic dose of Eurartesim™ under different food intake conditions on the cardiac activity, as expressed by ECG parameters.
Measured: before study drugs administration, during the 24 hrs post first and last dose and during follow-up
Effect of food on bioavailability of Eurartesim™
To evaluate the impact of high-fat/high-Kcal or high-fat/low-Kcal meals on the overall relative bioavailability of Eurartesim™ in respect to no food.
Measured: during the 24 hrs post first and last dose
To evaluate differences in PK and ECG profiles according to posology scheme
To compare, within the Eurartesim™ groups, the PK profiles and the QT intervals of subjects with a body weight below or equal and above 75kg
Measured: during the 24 hrs post first and last dose
relationship within the Pk parameters of active substances and ECG parameters
To evaluate the relationship between the PK parameters of Dihydroartemisinin and Piperaquine and the ECG parameters
Measured: during the 24 hrs post first and last dose
to asses general safety and tolerability of Eurartesim™
To assess the safety and tolerability of Eurartesim™ under different food intake conditions in healthy subjects
Measured: during the treatment and follow-up period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2010Dec 2010

First posted15 Apr 2010 (estimated)
Study startFeb 2010
Primary completionAug 2010
Study completionDec 2010

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 Malaria, FalciparumStudies 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: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 287 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01103830
Sponsor's protocol ID: ST3073-ST3074-DM-09-006
Status last verified: Jun 2011
First submitted: 12 Apr 2010
Last updated: 17 Jun 2011
Results posted: No
Data monitoring committee: No

Publications

Funck-Brentano C, Bacchieri A, Valentini G, Pace S, Tommasini S, Voiriot P, Ubben D, Duparc S, Evene E, Felices M, Corsi M. Effects of Dihydroartemisinin-Piperaquine Phosphate and Artemether-Lumefantrine on QTc Interval Prolongation. Sci Rep. 2019 Jan 28;9(1):777. doi: 10.1038/s41598-018-37112-6.
PubMed 30692558

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I, Randomized, Parallel Group Study to Evaluate the Effect of Multiple Oral Doses of Eurartesim on the QT/QTc Interval Compared to Riamet, Placebo and Moxifloxacin in Healthy Male and Female Volunteers
ClinicalTrials.gov ID: NCT01103830
Acronym / sponsor ID: ST3073-ST3074-DM-09-006
Conditions: Malaria, Falciparum
Keywords: P. falciparum Malaria, Eurartesim, ACT
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 287 participants (actual)
Lead sponsor: sigma-tau i.f.r. S.p.A.Industry (pharma, biotech, devices)
Collaborators: Medicines for Malaria Venture
Study start: Feb 2010
Primary completion: Aug 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 15 Apr 2010 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Group 1	Experimental	Drug: Eurartesim™3 or 4 tablets of Eurartesim™, depending of body weight, (3 tablets for subjects weighting less than 75 kg, 4 tablets for subjects weighting 75 kg or more), once daily from Day 1 to Day 3. Administration of Eurartesim will be in fed condition following a high-fat/low-Kcal meal.
Group 2	Active comparator	Drug: Riamet®4 tablets of Riamet® on Day -1 evening, 4 tablets of Riamet® bid (with an interval of 12 ± 0.5 h), in the morning and in the evening of Day 1 and Day 2, 4 tablets of Riamet® in the morning of Day 3. Administration of Riamet® will be in fed condition following a high-fat/low-Kcal meal.
Group 3	Other	Other: Placebo and finally Moxifloxacin3 or 4 tablets of Eurartesim™ placebo, depending of body weight, (3 tablets for subjects weighting less than 75 kg, 4 tablets for subjects weighting 75 kg or more), once daily from Day1 to Day 3. Administration will be in the morning, in fed condition, following a high-fat/low-Kcal meal 1 tablet of Izilox® (400 mg moxifloxacin) in fed condition following a high-fat/low-Kcal meal, on Day 4 morning.
Group 4	Experimental	Drug: Eurartesim™3 or 4 tablets of Eurartesim™, depending of body weight, (3 tablets for subjects weighting less than 75 kg, 4 tablets for subjects weighting 75 kg or more), once daily from Day 1 to Day 3. Administration of Eurartesim will be in fed condition following a high-fat/high-Kcal meal.
Group 5	Experimental	Drug: Eurartesim™3 or 4 tablets of Eurartesim™, depending of body weight, (3 tablets for subjects weighting less than 75 kg, 4 tablets for subjects weighting 75 kg or more), once daily from Day 1 to Day 3. Administration of Eurartesim will be in fasting condition.
Group 6	Other	Other: Placebo and finally Moxifloxacin3 or 4 tablets of Eurartesim™ placebo, depending of body weight, (3 tablets for subjects weighting less than 75 kg, 4 tablets for subjects weighting 75 kg or more), once daily from Day1 to Day 3. Administration will be in the morning, in fasting condition. 1 tablet of Izilox® (400 mg moxifloxacin) in fed condition following a high-fat/low-Kcal meal, on Day 4 morning.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Male or female Caucasian subject ≥ 18 and ≤ 50 years;
Good general health (by medical history and physical examination);
For male and female subjects of childbearing potential use a double contraception method;
For female subjects of childbearing potential only: negative plasma pregnancy test at Screening and at admission in the clinical unit;
Body mass index (BMI) ≥18 and ≤ 27 kg/m2;

Key exclusion criteria (19 listed)

A predictable poor compliance or inability to communicate well with the Investigator;
Unsuitable veins for repeated venipuncture.
Evidence of clinically relevant cardiovascular, renal, hepatic, hematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric diseases as judged by the Investigator;
A history of additional risk factors for Torsades des Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome);
The use of concomitant medications that prolong the QT/QTc interval;

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
Eurartesim™Also: Dihydroartemisinin and Piperaquine combination therapy3 or 4 tablets of Eurartesim™ (40mg Dihydroartemisinin and 320 mg Piperaquine phosphate), depending of body weight (3 tablets for subjects weighting less than 75 kg, 4 tablets for subjects weighting 75 kg or more), once daily from Day 1 to Day 3	Drug	Group 1
Riamet®Also: artemether and lumefantrine combination therapy4 tablets of Riamet® (20mg artemether/120mg lumefantrine) on Day -1 evening, 4 tablets of Riamet® bid (with an interval of 12 ± 0.5 h), in the morning and in the evening of Day 1 and Day 2, 4 tablets of Riamet® in the morning of Day 3.	Drug	Group 2
Placebo and finally MoxifloxacinAlso: moxifloxacin3 or 4 tablets of Eurartesim™ placebo, depending of body weight, (3 tablets for subjects weighting less than 75 kg, 4 tablets for subjects weighting 75 kg or more), once daily from Day1 to Day 3. 1 tablet of Izilox® (400 mg moxifloxacin) on Day 4 morning.	Other	Group 3
Eurartesim™Also: Dihydroartemisinin and Piperaquine combination therapy3 or 4 tablets of Eurartesim™ (40mg Dihydroartemisinin and 320 mg Piperaquine phosphate), depending of body weight (3 tablets for subjects weighting less than 75 kg, 4 tablets for subjects weighting 75 kg or more), once daily from Day 1 to Day 3.	Drug	Group 4
Eurartesim™Also: Dihydroartemisinin and Piperaquine combination therapy3 or 4 tablets of Eurartesim™ (40mg Dihydroartemisinin and 320 mg Piperaquine phosphate), depending of body weight (3 tablets for subjects weighting less than 75 kg, 4 tablets for subjects weighting 75 kg or more), once daily from Day 1 to Day 3.	Drug	Group 5
Placebo and finally MoxifloxacinAlso: moxifloxacin3 or 4 tablets of Eurartesim™ placebo, depending of body weight, (3 tablets for subjects weighting less than 75 kg, 4 tablets for subjects weighting 75 kg or more), once daily from Day1 to Day 3. 1 tablet of Izilox® (400 mg moxifloxacin)on Day 4 morning.	Other	Group 6

Primary outcome

QTcF interval (Fridericia's correction QT interval)
Time frame: before study drugs administration, during the 24 hrs post first and third dose and during follow-up
Group 1,4 and 5 (Day -1: pre-dose, each hour till 13h post-dose. Day 1: pre-dose, 1, 2, 3, 4, 5, and 6 h post-dose. Day 3: pre-dose, each hour till 13h post-dose and then 24h). Group 2 (Day -2: pre-dose, each hour till 13h post-dose and then 24h. Day 3: pre-dose, each hour till 13h post-dose and then 24h). Group 3 and 6 (Day -1: pre-dose, each hour till 13h post-dose. Day 1: pre-dose, 1, 2, 3, 4, 6, 8, 12 and 24h post-dose. Day 3: pre-dose, pre-dose, each hour till 13h post-dose. Day 4: pre-dose, 1, 2, 3, 4, 6, 8, 12 and 24h post-dose).

5 secondary outcomes

Effect of Eurartesim™ administered in different food conditions, on ECG parameters
Time frame: before study drugs administration, during the 24 hrs post first and last dose and during follow-up
Effect of food on bioavailability of Eurartesim™
Time frame: during the 24 hrs post first and last dose
To evaluate differences in PK and ECG profiles according to posology scheme
Time frame: during the 24 hrs post first and last dose
relationship within the Pk parameters of active substances and ECG parameters
Time frame: during the 24 hrs post first and last dose
to asses general safety and tolerability of Eurartesim™
Time frame: during the treatment and follow-up period

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 17 Jun 2011.
Derived from this study: PubMed 30692558Funck-Brentano C, Bacchieri A, Valentini G, Pace S, Tommasini S, Voiriot P, Ubben D, Duparc S, Evene E, Felices M, Corsi M. Effects of Dihydroartemisinin-Piperaquine Phosphate and Artemether-Lumefantrine on QTc Interval Prolongation. Sci Rep. 2019 Jan 28;9(1):777. doi: 10.1038/s41598-018-37112-6.

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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.

Lionel Hovsepian, MD principal investigator

SGS Aster S.A.S.

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 Eurartesim™ and Riamet® in people with Malaria, Falciparum, run by sigma-tau i.f.r. S.p.A. 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 9 inclusion and 19 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 17 Jun 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. 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?

QTcF interval (Fridericia's correction QT interval) (time frame: before study drugs administration, during the 24 hrs post first and third dose and during follow-up). 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 NCT01103830, 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 17 Jun 2011.