Study Stopped
Slow recruitment; trial unlikely to reach completion
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
1 other identifier
interventional
12
1 country
1
Brief Summary
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
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started May 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2009
CompletedStudy Start
First participant enrolled
May 15, 2009
CompletedFirst Posted
Study publicly available on registry
May 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2010
CompletedJuly 21, 2017
July 1, 2017
1.1 years
May 7, 2009
July 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect of the study treatments on Resting Motor Thresholds (rMT)
Within 24 hours
Secondary Outcomes (1)
The safety and tolerability of the combination of study treatments.
Within 24 hours
Study Arms (20)
Treatment sequence A
EXPERIMENTALSubjects 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.
Treatment sequence B
EXPERIMENTALSubjects 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.
Treatment sequence C
EXPERIMENTALSubjects 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.
Treatment sequence D
EXPERIMENTALSubjects 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.
Treatment sequence E
EXPERIMENTALSubjects 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.
Treatment sequence F
EXPERIMENTALSubjects 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.
Treatment sequence G
EXPERIMENTALSubjects 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.
Treatment sequence H
EXPERIMENTALSubjects 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.
Treatment sequence I
EXPERIMENTALSubjects 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.
Treatment sequence J
EXPERIMENTALSubjects 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.
Treatment sequence K
EXPERIMENTALSubjects 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.
Treatment sequence L
EXPERIMENTALSubjects 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.
Treatment sequence M
EXPERIMENTALSubjects 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.
Treatment sequence N
EXPERIMENTALSubjects 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.
Treatment sequence O
EXPERIMENTALSubjects 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.
Treatment sequence P
EXPERIMENTALSubjects 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.
Treatment sequence Q
EXPERIMENTALSubjects 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.
Treatment sequence R
EXPERIMENTALSubjects 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.
Treatment sequence S
EXPERIMENTALSubjects 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.
Treatment sequence T
EXPERIMENTALSubjects 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Healthy subject
- Male aged 18-65
- Greater than 50kg weight
- BMI 19-29.9 kg/m2
You may not qualify if:
- Positive drug/alcohol screen
- Positive HIV antibody
- History of drug dependence
- History of neurological disease
- Pacemaker
- Smoker
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
GSK Investigational Site
Göttingen, Lower Saxony, 37075, Germany
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2009
First Posted
May 25, 2009
Study Start
May 15, 2009
Primary Completion
June 10, 2010
Study Completion
June 10, 2010
Last Updated
July 21, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.