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

NCT00199225 | Completed Phase 1

• 1 other identifier: IC012RUP/1/04
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Human Experimentation (Human Volunteers)

Keywords

Thorough study QT/QTc; Cardiac repolarization; QT prolongation

Outcome Measures

Primary Outcomes (1)

• 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).

Interventions

Rupatadine DRUG

moxifloxacin DRUG

Continous electrocardiographic register PROCEDURE

Pharmacokinetic profile PROCEDURE

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• J. Uriach and Company: lead

Study Sites (1)

Centre de Investigació de Medicaments-Intitut de Recerca-Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

MeSH Terms

Conditions

Long QT Syndrome

Interventions

rupatadine; Moxifloxacin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Esther G Donado, PhD

  J. Uriach and Company

  STUDY DIRECTOR

• Iñaki Izquierdo, MD

  J. Uriach and Company

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: February 1, 2005
• Study Completion: July 1, 2005
• Last Updated: December 15, 2005

Record last verified: 2005-09

Locations

ES (1)