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
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.
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Fase
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
Niedersachsen
-
Goettingen, Niedersachsen, Tyskland, 37075
- GSK Investigational Site
-
-
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
|
Eksperimentel: 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.
|
|
Eksperimentel: 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.
|
|
Eksperimentel: 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.
|
|
Eksperimentel: 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.
|
|
Eksperimentel: 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.
|
|
Eksperimentel: 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.
|
|
Eksperimentel: 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.
|
|
Eksperimentel: 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.
|
|
Eksperimentel: 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.
|
|
Eksperimentel: 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.
|
|
Eksperimentel: 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.
|
|
Eksperimentel: 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.
|
|
Eksperimentel: 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.
|
|
Eksperimentel: 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.
|
|
Eksperimentel: 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.
|
|
Eksperimentel: 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.
|
|
Eksperimentel: 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.
|
|
Eksperimentel: 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.
|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Effect of the study treatments on Resting Motor Thresholds (rMT)
Tidsramme: Within 24 hours
|
Within 24 hours
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
The safety and tolerability of the combination of study treatments.
Tidsramme: Within 24 hours
|
Within 24 hours
|
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
Studieafslutning (Faktiske)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Bipolære og relaterede lidelser
- Maniodepressiv
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Depressive midler til centralnervesystemet
- Autonome agenter
- Agenter fra det perifere nervesystem
- Antiemetika
- Gastrointestinale midler
- Antipsykotiske midler
- Beroligende midler
- Psykotropiske stoffer
- Membrantransportmodulatorer
- Antikonvulsiva
- Natriumkanalblokkere
- Calciumregulerende hormoner og midler
- Calciumkanalblokkere
- Neurokinin-1-receptorantagonister
- Lamotrigin
- Vofopitant
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- 112676
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Studiedata/dokumenter
-
Formular til informeret samtykke
Informations-id: 112676Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Klinisk undersøgelsesrapport
Informations-id: 112676Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Annoteret sagsbetænkningsformular
Informations-id: 112676Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Studieprotokol
Informations-id: 112676Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Statistisk analyseplan
Informations-id: 112676Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Datasætspecifikation
Informations-id: 112676Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Individuelt deltagerdatasæt
Informations-id: 112676Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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