NCT00199225

Evaluation of Possible Effects on the QT/ QTc Interval of Rupatadine in Healthy Volunteers

Evaluation of Possible Effects on the QT/ QTc Interval of Rupatadine in Healthy Volunteers: A Randomised, Parallel, Placebo and Positive Controlled Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 160 (planned)
• Sponsor: J. Uriach and Company · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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 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

Conditions

• Human Experimentation (Human Volunteers)

Interventions

Type	Name	Description
DRUG	Rupatadine
DRUG	moxifloxacin
PROCEDURE	Continous electrocardiographic register
PROCEDURE	Pharmacokinetic profile

Timeline

• Start date: 2005-02-01
• Completion: 2005-07-01
• First posted: 2005-09-20
• Last updated: 2005-12-15

Locations

1 site across 1 country: Spain