Evaluation of Possible Effects on the QT/ QTc Interval of Rupatadine in Healthy Volunteers
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|ClinicalTrials.gov Identifier: NCT00199225|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : December 15, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|Human Experimentation (Human Volunteers)||Drug: Rupatadine Drug: moxifloxacin Procedure: Continous electrocardiographic register Procedure: Pharmacokinetic profile||Phase 1|
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
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Evaluation of Possible Effects on the QT/ QTc Interval of Rupatadine in Healthy Volunteers: A Randomised, Parallel, Placebo and Positive Controlled Study|
|Study Start Date :||February 2005|
|Study Completion Date :||July 2005|
- 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.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00199225
|Centre de Investigació de Medicaments-Intitut de Recerca-Hospital de la Santa Creu i Sant Pau|
|Barcelona, Spain, 08025|
|Principal Investigator:||Manuel Barbanoj, MD||Institut de Recerca-Hospital de la Santa Creu i Sant Pau|
|Principal Investigator:||Rosa Mª Antonijoan, MD||Institut de Recerca- Hospital de la Santa Creu i Sant Pau|
|Study Director:||Esther G Donado, PhD||J. Uriach and Company|
|Study Chair:||Iñaki Izquierdo, MD||J. Uriach and Company|