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
NCT ID: NCT00907985
Last Updated: 2017-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
12 participants
INTERVENTIONAL
2009-05-15
2010-06-10
Brief Summary
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1. Assess the effects of drug A and drug B on muscle movement after brain stimulation;
2. Examine how the body handles (absorbs, distributes, breaks down and gets rid of) drug A and drug B when given in combination;
3. Examine the safety of drug A and drug B when given together.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Placebo
Single dose of placebo will be provided.
Vofopitant
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.
Lamotrigine
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
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.
Placebo
Single dose of placebo will be provided.
Vofopitant
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.
Lamotrigine
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
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.
Placebo
Single dose of placebo will be provided.
Vofopitant
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.
Lamotrigine
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
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.
Placebo
Single dose of placebo will be provided.
Vofopitant
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.
Lamotrigine
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
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.
Placebo
Single dose of placebo will be provided.
Vofopitant
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.
Lamotrigine
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
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.
Placebo
Single dose of placebo will be provided.
Vofopitant
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.
Lamotrigine
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
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.
Placebo
Single dose of placebo will be provided.
Vofopitant
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.
Lamotrigine
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
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.
Placebo
Single dose of placebo will be provided.
Vofopitant
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.
Lamotrigine
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
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.
Placebo
Single dose of placebo will be provided.
Vofopitant
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.
Lamotrigine
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
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.
Placebo
Single dose of placebo will be provided.
Vofopitant
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.
Lamotrigine
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
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.
Placebo
Single dose of placebo will be provided.
Vofopitant
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.
Lamotrigine
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
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.
Placebo
Single dose of placebo will be provided.
Vofopitant
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.
Lamotrigine
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
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.
Placebo
Single dose of placebo will be provided.
Vofopitant
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.
Lamotrigine
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
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.
Placebo
Single dose of placebo will be provided.
Vofopitant
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.
Lamotrigine
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
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.
Placebo
Single dose of placebo will be provided.
Vofopitant
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.
Lamotrigine
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
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.
Placebo
Single dose of placebo will be provided.
Vofopitant
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.
Lamotrigine
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
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.
Placebo
Single dose of placebo will be provided.
Vofopitant
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.
Lamotrigine
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
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.
Placebo
Single dose of placebo will be provided.
Vofopitant
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.
Lamotrigine
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
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.
Placebo
Single dose of placebo will be provided.
Vofopitant
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.
Lamotrigine
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
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.
Placebo
Single dose of placebo will be provided.
Vofopitant
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.
Lamotrigine
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
Interventions
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Placebo
Single dose of placebo will be provided.
Vofopitant
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.
Lamotrigine
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
Eligibility Criteria
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Inclusion Criteria
* Male aged 18-65
* Greater than 50kg weight
* BMI 19-29.9 kg/m2
Exclusion Criteria
* Positive HIV antibody
* History of drug dependence
* History of neurological disease
* Pacemaker
* Smoker
18 Years
65 Years
MALE
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Göttingen, Lower Saxony, Germany
Countries
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Study Documents
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Document Type: Informed Consent Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Clinical Study Report
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Annotated Case Report Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Study Protocol
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Statistical Analysis Plan
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Dataset Specification
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Individual Participant Data Set
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentRelated Links
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Other Identifiers
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112676
Identifier Type: -
Identifier Source: org_study_id
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