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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Drug: Placebo
* Drug: Vofopitant
* Drug: Lamotrigine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment sequence A<br>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. | Drug: Placebo<br>* Single dose of placebo will be provided.<br>Drug: Vofopitant<br>* Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.<br>Drug: Lamotrigine<br>* Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.<br>|
| Experimental: Treatment sequence B<br>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. | Drug: Placebo<br>* Single dose of placebo will be provided.<br>Drug: Vofopitant<br>* Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.<br>Drug: Lamotrigine<br>* Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.<br>|
| Experimental: Treatment sequence C<br>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. | Drug: Placebo<br>* Single dose of placebo will be provided.<br>Drug: Vofopitant<br>* Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.<br>Drug: Lamotrigine<br>* Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.<br>|
| Experimental: Treatment sequence D<br>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. | Drug: Placebo<br>* Single dose of placebo will be provided.<br>Drug: Vofopitant<br>* Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.<br>Drug: Lamotrigine<br>* Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.<br>|
| Experimental: Treatment sequence E<br>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. | Drug: Placebo<br>* Single dose of placebo will be provided.<br>Drug: Vofopitant<br>* Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.<br>Drug: Lamotrigine<br>* Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.<br>|
| Experimental: Treatment sequence F<br>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. | Drug: Placebo<br>* Single dose of placebo will be provided.<br>Drug: Vofopitant<br>* Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.<br>Drug: Lamotrigine<br>* Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.<br>|
| Experimental: Treatment sequence G<br>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. | Drug: Placebo<br>* Single dose of placebo will be provided.<br>Drug: Vofopitant<br>* Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.<br>Drug: Lamotrigine<br>* Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.<br>|
| Experimental: Treatment sequence H<br>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. | Drug: Placebo<br>* Single dose of placebo will be provided.<br>Drug: Vofopitant<br>* Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.<br>Drug: Lamotrigine<br>* Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.<br>|
| Experimental: Treatment sequence I<br>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. | Drug: Placebo<br>* Single dose of placebo will be provided.<br>Drug: Vofopitant<br>* Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.<br>Drug: Lamotrigine<br>* Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.<br>|
| Experimental: Treatment sequence J<br>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. | Drug: Placebo<br>* Single dose of placebo will be provided.<br>Drug: Vofopitant<br>* Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.<br>Drug: Lamotrigine<br>* Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.<br>|
| Experimental: Treatment sequence K<br>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. | Drug: Placebo<br>* Single dose of placebo will be provided.<br>Drug: Vofopitant<br>* Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.<br>Drug: Lamotrigine<br>* Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.<br>|
| Experimental: Treatment sequence L<br>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. | Drug: Placebo<br>* Single dose of placebo will be provided.<br>Drug: Vofopitant<br>* Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.<br>Drug: Lamotrigine<br>* Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.<br>|
| Experimental: Treatment sequence M<br>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. | Drug: Placebo<br>* Single dose of placebo will be provided.<br>Drug: Vofopitant<br>* Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.<br>Drug: Lamotrigine<br>* Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.<br>|
| Experimental: Treatment sequence N<br>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. | Drug: Placebo<br>* Single dose of placebo will be provided.<br>Drug: Vofopitant<br>* Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.<br>Drug: Lamotrigine<br>* Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.<br>|
| Experimental: Treatment sequence O<br>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. | Drug: Placebo<br>* Single dose of placebo will be provided.<br>Drug: Vofopitant<br>* Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.<br>Drug: Lamotrigine<br>* Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.<br>|
| Experimental: Treatment sequence P<br>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. | Drug: Placebo<br>* Single dose of placebo will be provided.<br>Drug: Vofopitant<br>* Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.<br>Drug: Lamotrigine<br>* Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.<br>|
| Experimental: Treatment sequence Q<br>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. | Drug: Placebo<br>* Single dose of placebo will be provided.<br>Drug: Vofopitant<br>* Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.<br>Drug: Lamotrigine<br>* Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.<br>|
| Experimental: Treatment sequence R<br>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. | Drug: Placebo<br>* Single dose of placebo will be provided.<br>Drug: Vofopitant<br>* Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.<br>Drug: Lamotrigine<br>* Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.<br>|
| Experimental: Treatment sequence S<br>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. | Drug: Placebo<br>* Single dose of placebo will be provided.<br>Drug: Vofopitant<br>* Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.<br>Drug: Lamotrigine<br>* Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.<br>|
| Experimental: Treatment sequence T<br>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. | Drug: Placebo<br>* Single dose of placebo will be provided.<br>Drug: Vofopitant<br>* Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.<br>Drug: Lamotrigine<br>* Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of the study treatments on Resting Motor Thresholds (rMT) |  | Within 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety and tolerability of the combination of study treatments. |  | Within 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Volunteer, Resting motor threshold (rMT), Transcranial magnetic stimulation (TMS)