Human Experimentation (Human Volunteers)Phase 1NCT00199225
Evaluation of Possible Effects on the QT/ QTc Interval of Rupatadine in Healthy Volunteers
A Phase 1 study testing Rupatadine, moxifloxacin and Continous electrocardiographic register in people with Human Experimentation (Human Volunteers), run by J. Uriach and Company at 1 site in Spain.
Trial summary
This phase I trial will evaluate the effects of rupatadine, at a dose of 10 mg OD (authorised and marketed dose) and the 100mg/day (supratherapeutic dose) on the ECG parameters with a special focus on its effect on cardiac repolarisation (QTc interval duration).Furthermore, the study is performed to assess the… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Experimentation (Human Volunteers)
- What is being tested?
- Rupatadine, moxifloxacin and Continous electrocardiographic register
- Type of treatment
- Surgery or procedure
- How many people
- 160 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2005to Jul 2005
- 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
- Subjects meeting all of the following criteria will be considered for admission to the study:
- Male or female between 18 and 45 years old (inclusive)
- In good health as determined by the principal investigator based on medical history, physical examination, ECG, and clinical laboratory tests
- Body Mass Index between 19 and 27 kg/m2.
- Non-smokers (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 6 months prior to the administration of the study medication)
- Negative serology Hepatitis B, C or HIV in the 3 previous months
- Female subjects must have a negative serum pregnancy test result prior to enrollment into the study. Female subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within one year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e. less than 1% per year, when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices [IUDs], sexual abstinence, or a vasectomised partner) during the entire duration of the study. Oral contraceptive medications are prohibited in this study
- Capable of understanding and complying with the protocol and must have signed the informed consent document prior to performance of any study-related procedures
Who cannot join
- Subjects presenting with any of the following will not be included in the study:
- Currently abusing drugs or alcohol (> 30 gr/day; or > 1/2 drinks/day for females/males, defined according to USDA Dietary Guidelines 2000) or with a history of drug or alcohol abuse within the past two years
- Subjects will be asked to consume xanthine-containing food and beverages (eg, coffee, tea, chocolate, and cola beverages).
- Has taken any grapefruit or grapefruit juice during 14 days prior the screening visit and day -1.
- Unwilling or unable to comply with the protocol or reside in the study unit during the study period or to cooperate fully with the principal investigator and site personnel
- Has used any prescription medication within 14 days prior to Day 0, or over-the-counter (OTC) medication, herbal preparations, and/or vitamins within 48 hours prior to the start of study drug administration on Day 0
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- A 12 lead ECG obtained at screening with: PR > 240 msec, QRS >110 msec and QTc > 430 msec in males or QTc > 430 msec in females, bradycardia (<50 lpm) or clinically significant minor STT wave changes on the screening ECG, or any other changes on the screening ECG that would interfere with measurement of the QT interval
- Has a serum potassium, sodium, calcium, or magnesium level that is not within normal limits or has other laboratory values outside the normal range at the screening visit that are deemed by the principal investigator to make the subject an inappropriate candidate for the study
- Has taken any other investigational drug during the 2 months prior to screening visit
- Has donated or lost more than a unit of blood within 30 days prior to screening visit
- Has any condition(s) that in the investigator's opinion would: a) warrant exclusion from the study or b) prevent the subject from completing the study
- Unable to understand verbal and/or written the informed consent.
- History of hypersensitivity or allergic reaction to moxifloxacin or any other member of the quinolone class of antibiotics
- History of hypersensitivity or allergic reaction to rupatadine or any other antihistamine compounds
- Furthermore, will be excluded during the study all the subjects that shows any waiver to the inclusion or exclusion criteria, under the criteria of principal investigator and/or medical monitor.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Centre de Investigació de Medicaments-Intitut de Recerca-Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08025
About this study
Official title: Evaluation of Possible Effects on the QT/ QTc Interval of Rupatadine in Healthy Volunteers: A Randomised, Parallel, Placebo and Positive Controlled Study
This phase I trial will evaluate the effects of rupatadine, at a dose of 10 mg OD (authorised and marketed dose) and the 100mg/day (supratherapeutic dose) on the ECG parameters with a special focus on its effect on cardiac repolarisation (QTc interval duration).Furthermore, the study is performed to assess the pharmacokinetic-pharmacodynamic relationship between plasma concentration of rupatadine and its effects, if any, on cardiac repolarisation mainly in the QTc interval).
The main objective is to assess whether administration of a repeated dose of 10 and 100 mg/day , has the potential to cause QT prolongation in healthy volunteers.
Read the detailed description
Recently, as FDA as EMEA provides recommendations to sponsors concerning the design, conduct, analysis and interpretation of clinical studies to assess the potential for delaying cardiac repolarisation. This paper recommends to perform a 'through Qt/QTc' study to expand ECGs safety evaluation during later stages of drug development. It was recomended that the study was randomized, blind and placebo controlled. Moreover, as a high sensitivy is necessary in order to detect differences in the QTc measure, it was essential a positive control included. On that basis, the positive control should be well-characterized and consistently produce an effect corresponding to the largest change in the QT/QTc interval that is currently viewed as clinically not important to detect (a mean change of around 5 ms. Because of this, we decide select as positive control: moxifloxacin, used in the most of similar phase I clinical trials.
In these type of studies, as recommended by the guidelines, there should be a caracterization to ensure that the dose-response and generally the concentration-response relationship for QT/QTc prolongation, including exploration of concentrations that are higher than those achieved following the therapeutic doses. So, thererfore, we decided use 100 mg/daY (10 times the therapeutic dose) as supratherapeutic dose to be administered.
We decide propose a new phase I study as recommended guidelines (a single-blind, randomised, placebo and active-controlled, parallel design). With this, we've tried complet the rupatadine effects over QTc and another electrocardiographic parameters and valued the risk-benefit relationship for this new antiH1 and PAF antagonist
single
- Conditions
- Human Experimentation (Human Volunteers)
- Being tested
- Rupatadine, moxifloxacin, Continous electrocardiographic register, Pharmacokinetic profile
- Keywords
- Thorough study QT/QTc, Cardiac repolarization, QT prolongation
- Medical subject headings
- Long QT Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RupatadineDrug
moxifloxacinDrug
Continous electrocardiographic registerProcedure or surgery
Pharmacokinetic profileProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess whether administration of a repeated dose of 10 and 100 mg/day , has the potential to cause QT prolongation in healthy volunteers, according the current guidelines.
Secondary outcomes (1)
Furthermore, the study is performed to assess the pharmacokinetic-pharmacodynamic relationship between plasma concentration of rupatadine and its effects, if any, on cardiac repolarisation mainly in the QTc interval).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startFeb 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Experimentation (Human Volunteers)Studies 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
- Enrolment
- 160 participants
Sponsor and investigators
- Lead sponsor
- J. Uriach and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Manuel Barbanoj, MD, Principal investigator, Institut de Recerca-Hospital de la Santa Creu i Sant PauRosa Mª Antonijoan, MD, Principal investigator, Institut de Recerca- Hospital de la Santa Creu i Sant PauEsther G Donado, PhD, Study director, J. Uriach and CompanyIñaki Izquierdo, MD, Study chair, J. Uriach and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199225
- Sponsor's protocol ID
- IC012RUP/1/04
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 15 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Possible Effects on the QT/ QTc Interval of Rupatadine in Healthy Volunteers: A Randomised, Parallel, Placebo and Positive Controlled Study
- ClinicalTrials.gov ID
- NCT00199225
- Acronym / sponsor ID
- IC012RUP/1/04
- Conditions
- Human Experimentation (Human Volunteers)
- Keywords
- Thorough study QT/QTc, Cardiac repolarization, QT prolongation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants
- Lead sponsor
- J. Uriach and CompanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- Study completion
- Jul 2005
- First posted
- 20 Sep 2005 (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.
This phase I trial will evaluate the effects of rupatadine, at a dose of 10 mg OD (authorised and marketed dose) and the 100mg/day (supratherapeutic dose) on the ECG parameters with a special focus on its effect on cardiac repolarisation (QTc interval duration).Furthermore, the study is performed to assess the pharmacokinetic-pharmacodynamic relationship between plasma concentration of rupatadine and its effects, if any, on cardiac repolarisation mainly in the QTc interval).
The main objective is to assess whether administration of a repeated dose of 10 and 100 mg/day , has the potential to cause QT prolongation in healthy volunteers.
Detailed description
Recently, as FDA as EMEA provides recommendations to sponsors concerning the design, conduct, analysis and interpretation of clinical studies to assess the potential for delaying cardiac repolarisation. This paper recommends to perform a 'through Qt/QTc' study to expand ECGs safety evaluation during later stages of drug development. It was recomended that the study was randomized, blind and placebo controlled. Moreover, as a high sensitivy is necessary in order to detect differences in the QTc measure, it was essential a positive control included. On that basis, the positive control should be well-characterized and consistently produce an effect corresponding to the largest change in the QT/QTc interval that is currently viewed as clinically not important to detect (a mean change of around 5 ms. Because of this, we decide select as positive control: moxifloxacin, used in the most of similar phase I clinical trials.
In these type of studies, as recommended by the guidelines, there should be a caracterization to ensure that the dose-response and generally the concentration-response relationship for QT/QTc prolongation, including exploration of concentrations that are higher than those achieved following the therapeutic doses. So, thererfore, we decided use 100 mg/daY (10 times the therapeutic dose) as supratherapeutic dose to be administered.
We decide propose a new phase I study as recommended guidelines (a single-blind, randomised, placebo and active-controlled, parallel design). With this, we've tried complet the rupatadine effects over QTc and another electrocardiographic parameters and valued the risk-benefit relationship for this new antiH1 and PAF antagonist
single
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subjects meeting all of the following criteria will be considered for admission to the study:
- Male or female between 18 and 45 years old (inclusive)
- In good health as determined by the principal investigator based on medical history, physical examination, ECG, and clinical laboratory tests
- Body Mass Index between 19 and 27 kg/m2.
- Non-smokers (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 6 months prior to the administration of the study medication)
Key exclusion criteria (15 listed)
- Currently abusing drugs or alcohol (> 30 gr/day; or > 1/2 drinks/day for females/males, defined according to USDA Dietary Guidelines 2000) or with a history of drug or alcohol abuse within the past two years
- Subjects will be asked to consume xanthine-containing food and beverages (eg, coffee, tea, chocolate, and cola beverages).
- Has taken any grapefruit or grapefruit juice during 14 days prior the screening visit and day -1.
- Unwilling or unable to comply with the protocol or reside in the study unit during the study period or to cooperate fully with the principal investigator and site personnel
- Has used any prescription medication within 14 days prior to Day 0, or over-the-counter (OTC) medication, herbal preparations, and/or vitamins within 48 hours prior to the start of study drug administration on Day 0
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 |
|---|---|---|
| Rupatadine | Drug | – |
| moxifloxacin | Drug | – |
| Continous electrocardiographic register | Procedure or surgery | – |
| Pharmacokinetic profile | Procedure or surgery | – |
Primary outcome
To assess whether administration of a repeated dose of 10 and 100 mg/day , has the potential to cause QT prolongation in healthy volunteers, according the current guidelines.
1 secondary outcome
Furthermore, the study is performed to assess the pharmacokinetic-pharmacodynamic relationship between plasma concentration of rupatadine and its effects, if any, on cardiac repolarisation mainly in the QTc interval).
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 Dec 2005.
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.
Manuel Barbanoj, MD principal investigator
Institut de Recerca-Hospital de la Santa Creu i Sant Pau
Rosa Mª Antonijoan, MD principal investigator
Institut de Recerca- Hospital de la Santa Creu i Sant Pau
Esther G Donado, PhD study director
J. Uriach and Company
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 Rupatadine, moxifloxacin and Continous electrocardiographic register in people with Human Experimentation (Human Volunteers), run by J. Uriach and Company at 1 site in Spain.
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 8 inclusion and 15 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 Dec 2005. 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 Spain. 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?
To assess whether administration of a repeated dose of 10 and 100 mg/day , has the potential to cause QT prolongation in healthy volunteers, according the current guidelines.. 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 15 Dec 2005.