Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00199225
Status:
COMPLETED
Last Update Posted:
2005-12-15
First Post:
2005-09-12
Brief Title:
Evaluation of Possible Effects on the QT QTc Interval of Rupatadine in Healthy Volunteers
Sponsor:
J Uriach and Company
Organization:
J Uriach and Company
Study Overview
Official Title:
Evaluation of Possible Effects on the QT QTc Interval of Rupatadine in Healthy Volunteers A Randomised Parallel Placebo and Positive Controlled Study
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial will evaluate the effects of rupatadine at a dose of 10 mg OD authorised and marketed dose and the 100mgday supratherapeutic dose on the ECG parameters with a special focus on its effect on cardiac repolarisation QTc interval durationFurthermore 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 mgday has the potential to cause QT prolongation in healthy volunteers
The main objective is to assess whether administration of a repeated dose of 10 and 100 mgday 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 QtQTc 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 QTQTc 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 QTQTc prolongation including exploration of concentrations that are higher than those achieved following the therapeutic doses So thererfore we decided use 100 mgdaY 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 weve 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
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 QTQTc prolongation including exploration of concentrations that are higher than those achieved following the therapeutic doses So thererfore we decided use 100 mgdaY 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 weve 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None