A Study to Evaluate the Effect of Single Doses of Drug A (Lamotrigine) and Drug B (Vofopitant) Alone and in Combination on Resting Motor Threshold in Healthy Subjects
18 juillet 2017 mis à jour par: GlaxoSmithKline
Double Blind, Double-dummy, Randomised, Placebo Controlled Study to Evaluate the Effect of Single Doses of Drug A (Lamotrigine) and Drug B (Vofopitant) Alone and in Combination on Resting Motor Threshold in Healthy Subjects
The purpose of this study is to investigate the effect of drug A on its own and when it is given in combination with drug B on markers of brain activity. The study will
- Assess the effects of drug A and drug B on muscle movement after brain stimulation;
- Examine how the body handles (absorbs, distributes, breaks down and gets rid of) drug A and drug B when given in combination;
- Examine the safety of drug A and drug B when given together.
Aperçu de l'étude
Statut
Résilié
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
12
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
-
-
Niedersachsen
-
Goettingen, Niedersachsen, Allemagne, 37075
- GSK Investigational Site
-
-
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 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Homme
La description
Inclusion Criteria:
- Healthy subject
- Male aged 18-65
- Greater than 50kg weight
- BMI 19-29.9 kg/m2
Exclusion Criteria:
- Positive drug/alcohol screen
- Positive HIV antibody
- History of drug dependence
- History of neurological disease
- Pacemaker
- Smoker
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
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Treatment sequence A
Subjects on sequence A will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of lamotrigine 175 milligrams tablet + vofopitant 10 milligrams capsule in session A of part 2 and placebo + vofopitant 10 milligrams capsule in session B of part 2.
|
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally.
It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
|
|
Expérimental: Treatment sequence B
Subjects on sequence B will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of placebo + vofopitant 10 milligrams capsule in session A of part 2 and lamotrigine 175 milligrams tablet + vofopitant 10 milligrams capsule in session B of part 2.
|
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally.
It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
|
|
Expérimental: Treatment sequence C
Subjects on sequence C will receive single dose of placebo in part 1, single doses of lamotrigine 175 milligrams tablet + vofopitant 10 milligrams capsule in session A of part 2 and placebo + vofopitant 10 milligrams capsule in session B of part 2.
|
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally.
It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
|
|
Expérimental: Treatment sequence D
Subjects on sequence D will receive single dose of placebo in part 1, single doses of placebo + vofopitant 10 milligrams capsule in session A of part 2 and lamotrigine 175 milligrams tablet + vofopitant 10 milligrams capsule in session B of part 2.
|
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally.
It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
|
|
Expérimental: Treatment sequence E
Subjects on sequence E will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of lamotrigine 175 milligrams tablet + vofopitant 10 milligrams capsule in session A of part 2 and placebo + placebo in session B of part 2.
|
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally.
It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
|
|
Expérimental: Treatment sequence F
Subjects on sequence F will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of placebo + placebo in session A of part 2 and lamotrigine 175 milligrams tablet + vofopitant 10 milligrams capsule in session B of part 2.
|
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally.
It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
|
|
Expérimental: Treatment sequence G
Subjects on sequence G will receive single dose of placebo in part 1, single doses of lamotrigine 175 milligrams tablet + vofopitant 10 milligrams capsule in session A of part 2 and placebo + placebo in session B of part 2.
|
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally.
It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
|
|
Expérimental: Treatment sequence H
Subjects on sequence H will receive single dose of placebo part 1, single doses of placebo + placebo in session A of part 2 and lamotrigine 175 milligrams tablet + vofopitant 10 milligrams capsule in session B of part 2.
|
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally.
It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
|
|
Expérimental: Treatment sequence I
Subjects on sequence I will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of lamotrigine 175 milligrams tablet + placebo in session A of part 2 and placebo + vofopitant 10 milligrams capsule in session B of part 2.
|
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally.
It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
|
|
Expérimental: Treatment sequence J
Subjects on sequence J will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of placebo + vofopitant 10 milligrams capsule in session A of part 2 and lamotrigine 175 milligrams tablet + placebo in session B of part 2.
|
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally.
It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
|
|
Expérimental: Treatment sequence K
Subjects on sequence K will receive single dose of placebo in part 1, single doses of lamotrigine 175 milligrams tablet + placebo in session A of part 2 and placebo + vofopitant 10 milligrams capsule in session B of part 2.
|
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally.
It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
|
|
Expérimental: Treatment sequence L
Subjects on sequence L will receive single dose of placebo in part 1, single doses of placebo + vofopitant 10 milligrams capsule in session A of part 2 and lamotrigine 175 milligrams tablet + placebo in session B of part 2.
|
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally.
It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
|
|
Expérimental: Treatment sequence M
Subjects on sequence M will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of lamotrigine 175 milligrams tablet + placebo in session A of part 2 and placebo + placebo in session B of part 2.
|
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally.
It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
|
|
Expérimental: Treatment sequence N
Subjects on sequence N will receive single dose of vofopitant 10 milligrams capsule in part 1, placebo + placebo in session A of part 2 and lamotrigine 175 milligrams tablet + placebo in session B of part 2.
|
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally.
It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
|
|
Expérimental: Treatment sequence O
Subjects on sequence O will receive placebo in part 1, single doses of lamotrigine 175 milligrams tablet + placebo in session A of part 2 and placebo + placebo in session B of part 2.
|
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally.
It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
|
|
Expérimental: Treatment sequence P
Subjects on sequence P will receive placebo in part 1, single doses of placebo + placebo in session A of part 2 and lamotrigine 175 milligrams tablet + placebo in session B of part 2.
|
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally.
It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
|
|
Expérimental: Treatment sequence Q
Subjects on sequence Q will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of lamotrigine 175 milligrams tablet + lamotrigine 150 milligrams tablet in session A of part 2 and placebo + placebo in session B of part 2.
|
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally.
It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
|
|
Expérimental: Treatment sequence R
Subjects on sequence R will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of placebo + placebo in session A of part 2 and lamotrigine 175 milligrams tablet + lamotrigine 150 milligrams tablet in session B of part 2.
|
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally.
It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
|
|
Expérimental: Treatment sequence S
Subjects on sequence S will receive placebo in part 1, single doses of lamotrigine 175 milligrams tablet + lamotrigine 150 milligrams tablet in session A of part 2 and placebo + placebo in session B of part 2.
|
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally.
It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
|
|
Expérimental: Treatment sequence T
Subjects on sequence T will receive placebo in part 1, single doses of placebo + placebo in session A of part 2 and lamotrigine 175 milligrams tablet + lamotrigine 150 milligrams tablet in session B of part 2.
|
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally.
It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Effect of the study treatments on Resting Motor Thresholds (rMT)
Délai: Within 24 hours
|
Within 24 hours
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
The safety and tolerability of the combination of study treatments.
Délai: Within 24 hours
|
Within 24 hours
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
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 (Réel)
15 mai 2009
Achèvement primaire (Réel)
10 juin 2010
Achèvement de l'étude (Réel)
10 juin 2010
Dates d'inscription aux études
Première soumission
7 mai 2009
Première soumission répondant aux critères de contrôle qualité
21 mai 2009
Première publication (Estimation)
25 mai 2009
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
21 juillet 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
18 juillet 2017
Dernière vérification
1 juillet 2017
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Les troubles mentaux
- Troubles bipolaires et apparentés
- Trouble bipolaire
- Effets physiologiques des médicaments
- Agents neurotransmetteurs
- Mécanismes moléculaires de l'action pharmacologique
- Dépresseurs du système nerveux central
- Agents autonomes
- Agents du système nerveux périphérique
- Antiémétiques
- Agents gastro-intestinaux
- Agents antipsychotiques
- Agents tranquillisants
- Médicaments psychotropes
- Modulateurs de transport membranaire
- Anticonvulsivants
- Bloqueurs des canaux sodiques
- Hormones et agents régulateurs du calcium
- Bloqueurs de canaux calciques
- Antagonistes des récepteurs de la neurokinine-1
- Lamotrigine
- Vofopitant
Autres numéros d'identification d'étude
- 112676
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Données/documents d'étude
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Formulaire de consentement éclairé
Identifiant des informations: 112676Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
-
Rapport d'étude clinique
Identifiant des informations: 112676Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
-
Formulaire de rapport de cas annoté
Identifiant des informations: 112676Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
-
Protocole d'étude
Identifiant des informations: 112676Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
-
Plan d'analyse statistique
Identifiant des informations: 112676Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
-
Spécification du jeu de données
Identifiant des informations: 112676Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
-
Ensemble de données de participant individuel
Identifiant des informations: 112676Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
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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