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- Essai clinique NCT00978614
Evaluation of Dose-Dependent Repeated-Dose Neramexane Effects on Cardiac Repolarisation (QT/QTc Interval Duration): Electrocardiogram (ECG) Study in Healthy Adult Subjects
14 février 2011 mis à jour par: Merz Pharmaceuticals GmbH
Valuation of Dose-Dependent Repeated-Dose Neramexane Effects on Cardiac Repolarisation (QT/QTc Interval Duration) Randomized, Double-Blind, Placebo- and Moxifloxacin-Controlled, Ascending Repeated-Dose, Three-Arm Parallel Design ECG Study in Healthy Adult Subjects
Primary:
- To assess the effects of ascending repeated-doses of oral [p.o.] neramexane at therapeutic and supra-therapeutic steady-state doses on cardiac repolarisation (QT/QTc interval) in healthy male and female subjects.
Secondary:
- To assess the pharmacokinetics [PK] of neramexane and N-OH neramexane (if a validated method will be available for this metabolite) following repeated daily doses of 50 mg (steady state), 75 mg (steady state) and 87.5 mg (steady state).
- To assess the safety and tolerability of neramexane 50 mg, 62.5 mg, 75 mg and 87.5 mg repeated-dose treatments when gradually up-titrated in healthy subjects.
- To assess the concentration-QT relationship.
Aperçu de l'étude
Type d'étude
Interventionnel
Inscription (Anticipé)
126
Phase
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Berlin, Allemagne, 14050
- Parexel International GmbH
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 45 ans (Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Healthy adult subject confirmed on the basis of extensive pre-study screening investigations
- Aged 18 to 45, inclusive
- Body mass index [BMI] of 18-28 kg/m² (inclusive) and a body weight of 50 -<90 kg
- Willing and able to provide written informed consent after having been informed of the requirements and the restrictions of the study
- Female subject of child-bearing potential must agree to use a non-hormonal highly effective method of birth control defined as those which result in a low failure rate when used consistently and correctly, such as sexual abstinence, vasectomized partner, non-hormone releasing intrauterine devices [IUDs].
A sexually active man, who has not been sterilized surgically, must agree to use together with his female partner a double contraception method during intercourse:
- IUD or hormonal contraception plus condom or diaphragm or spermicide, or
- condom plus diaphragm or observe abstinence during the entire clinical study until the Final Examination.
Exclusion Criteria:
- History of clinically relevant allergy or known hypersensitivity to neramexane/memantine/amantadine and their derivatives
- History of clinically relevant allergy or known hypersensitivity to moxifloxacin or any other quinolone antibiotics
- History of clinically relevant allergy or known hypersensitivity to any inactive ingredient in any of the used investigational products or positive control especially quinine
- Any contraindications which are indicated in the current SPC of Avalox®
- Evidence or (family) history of long QT syndrome
- Exposure to another investigational agent within the last two months before Day -1
- Lactating or pregnant female, or female planning to become pregnant during study conduct
- Any evidence of a significant cardiovascular, pulmonary, renal, hepatic, gastrointestinal, endocrinological, metabolic (acidosis), psychiatric, neurologic, relevant eye disorder or other diseases at screening
- ECG abnormalities of clinical relevance, in particular abnormal prolongations of QT/QTc-interval (i.e. QTc >450 ms, PQ ≥220 ms)
- Systolic blood pressure <95 mmHg or >140 mmHg or diastolic blood pressure <50 mmHg or >95 mmHg in semi-supine position
- Pulse rate <45 or >100 beats per minute
- History of malignancy
- Any clinically relevant deviation in clinical or laboratory assessment
- Acute or chronic clinically relevant infections
- Current evidence of hypokalemia and/or hypomagnesemia (= below lower limit of laboratory normal range plus 0.3 mmol/L as safety margin)
- History of alcohol or illicit drug abuse
- Alcohol consumption averaging more than 40 g for male and more than 20 g for female subjects daily within the last year
- Alcohol consumption within the last 48 hours prior to Day -1 or illicit drug intake in the 4 weeks prior to Day -1
- Disorders or surgery of the gastrointestinal tract which may interfere with drug absorption or may otherwise influence the pharmacokinetics of the investigational medicinal products (e.g. cholecystectomy, resections of small or large intestine, febrile conditions, chronic diarrhea, chronic vomiting, endocrine disease severe infections, acute inflammations, etc.)
- Allergy to band aid
- Use of any prescribed drugs in the 4 weeks prior to Day -1
- Regular use of over-the-counter [OTC] drugs (except paracetamol, maximum 1 g/day) in the 4 weeks prior to Day -1
- Occasional use of OTC drugs (except paracetamol, maximum 1 g/day) in the 2 weeks prior to Day -1
- Use of any food, food supplement or medication known to induce or inhibit cytochrome P450 [CYP] 2B6 or any other clinical relevant CYP enzymes within two weeks preceding Day -1 (e.g. grapefruit, St. Johns wort)
- Regular caffeine consumption averaging more than 1 L of coffee and/or tea daily or more than 1 L of caffeine-containing lemonades per day within the last year
- Female subject who employed any form of hormonal contraception within 2 months prior to study Day -1 (e.g. oral contraceptives, hormone releasing IUDs, etc.)
- Consume of xanthine derivates (including coffee, tea, chocolate, etc.) or quinine containing beverages (Bitter Lemon, Tonic Water, etc.) within two days prior to Day -1
- Smoker
- Previous participation in the drug administration phase of this trial
- Blood donation more than 450 mL within 60 days prior to Day -2
- Positive results in any of the serology tests (Human Immunodeficiency Virus [HIV1/2] antibodies, hepatitis B surface antigen, antibodies against hepatitis C virus)
- Positive pregnancy test
- Positive drug screen or alcohol test
- Excessive sports within 3 days before Day -2
- Sauna within 48 hours before Day -2
- Employee or direct relative of an employee of the CRO or Merz Pharmaceuticals
- Evidence or suspicion that the subject might not comply with the study directives and/or that he/she is not reliable or trustworthy
- Evidence or suspicion that the subject is not willing or unable to understand the information that is given to him/her as part of the informed consent, in particular regarding the risks and discomfort to which he/she would agree to be exposed
- Vulnerable subject (e.g. person kept in detention)
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Neramexane, Placebo, Moxifloxacin
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Dosage form: 25 mg immediate release [IR] tablets (=15.9 mg neramexane free base) 37.5 mg IR tablets (=23.9 mg neramexane free base) |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
To assess the effects of ascending repeated-doses of oral [p.o.] neramexane at therapeutic and supra-therapeutic steady-state doses on cardiac repolarisation (QT/QTc interval) in healthy male and female subjects.
Délai: steady state, therapeutic dose
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steady state, therapeutic dose
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 septembre 2009
Achèvement primaire (Réel)
1 avril 2010
Achèvement de l'étude (Réel)
1 avril 2010
Dates d'inscription aux études
Première soumission
10 septembre 2009
Première soumission répondant aux critères de contrôle qualité
16 septembre 2009
Première publication (Estimation)
17 septembre 2009
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
15 février 2011
Dernière mise à jour soumise répondant aux critères de contrôle qualité
14 février 2011
Dernière vérification
1 février 2011
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- MRZ 92579/TI/1006
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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