Assessment of Electrophysiological Effects of Dabigatran Etexilate as Single Dose on the QT Interval in Healthy Female and Male Subjects.
Assessment of Electrophysiological Effects of 150 mg and 600 mg of Dabigatran Etexilate as Single Dose on the QT Interval in Healthy Female and Male Subjects. A Randomised, Placebo Controlled, Double-blind Three-way Crossover Study With an Open Label Positive Control (Moxifloxacin)
Aperçu de l'étude
Statut
Statut
Les conditions
Les conditions
Intervention / Traitement
Intervention / Traitement
Type d'étude
Type d'étude
Inscription (Réel)
Inscription
Phase
Phase
- La phase 1
Critères de participation
Critère d'éligibilité
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Healthy female (at least 1/3) and male (at least 1/3) volunteers as determined by the results of screening according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, HR), 12-lead ECG, clinical laboratory tests
- Age >= 18 and Age <= 65 years
- BMI >= 20.0 and BMI <=29.9 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation
Exclusion Criteria:
- Any finding of the medical examination (including BP, pulse rate (PR) and ECG) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
- Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
- Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
- Participation in another trial with an investigational drug within two months prior to administration or during the trial
- Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (more than 60 g/day)
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- History of any bleeding disorder or acute blood coagulation defect
- Hypersensitivity to moxifloxacin and/or related drugs of this class
- Excessive physical activities (within one week prior to administration or during the trial)
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of study centre
- History of additional risk factors for Torsade des Pointes (e.g. heart failure, hypokalemia, family history of long QT syndrome)
Any screening ECG value outside of the reference range of clinical relevance including, but not limited to heart rate of >80 bpm or <45 bpm, PR interval >220 ms, QRS interval >120 ms, QT interval >470 ms or QTcB or QTcF >450 ms
For female subjects:
- Pregnancy
- Positive pregnancy test
- No adequate contraception e.g. oral contraceptives, sterilisation, intrauterine device (IUD)
- Inability to maintain this adequate contraception during the whole study period
- Lactation period
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Double
Nombre de bras
Armes et Interventions
Groupe de participants / BrasGroupe de participants / Bras |
Intervention / TraitementIntervention / Traitement |
|---|---|
|
Comparateur actif: Moxifloxacine
|
|
|
Expérimental: Dabigatran etexilate bas
|
|
|
Expérimental: Dabigatran etexilate élevé
|
|
|
Comparateur placebo: Placebo to dabigatran etexilate
|
Que mesure l'étude ?
Principaux critères de jugement
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Change from baseline in mean time-matched QTc Interval
Délai: at 1.5, 2, and 3 hours following administration
|
at 1.5, 2, and 3 hours following administration
|
Mesures de résultats secondaires
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Mean of the QTcI values of all ECGs
Délai: from 1 to 6 hours following administration
|
from 1 to 6 hours following administration
|
|
Change from baseline of the QTcI
Délai: from 1 to 24 hours following administration
|
from 1 to 24 hours following administration
|
Collaborateurs et enquêteurs
Parrainer
Parrainer
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement primaire
Dates d'inscription aux études
Première soumission
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Première publication
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour publiée
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Mécanismes moléculaires de l'action pharmacologique
- Agents anti-infectieux
- Inhibiteurs d'enzymes
- Agents antinéoplasiques
- Inhibiteurs de protéase
- Inhibiteurs de la topoisomérase II
- Inhibiteurs de la topoisomérase
- Agents antibactériens
- Antithrombines
- Inhibiteurs de la sérine protéinase
- Anticoagulants
- Moxifloxacine
- Dabigatran
Autres numéros d'identification d'étude
Autres numéros d'identification d'étude
- 1160.54
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