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

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Terminated

CT.gov ID

NCT00907985

Collaborator

(none)

Enrollment

Location

Arms

12.8

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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

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.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder	Drug: Placebo Drug: Vofopitant Drug: Lamotrigine	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 15, 2009

Actual Primary Completion Date :

Jun 10, 2010

Actual Study Completion Date :

Jun 10, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Placebo Single dose of placebo will be provided. Drug: Vofopitant Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules. Drug: Lamotrigine Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
Experimental: 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.	Drug: Placebo Single dose of placebo will be provided. Drug: Vofopitant Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules. Drug: Lamotrigine Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
Experimental: 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.	Drug: Placebo Single dose of placebo will be provided. Drug: Vofopitant Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules. Drug: Lamotrigine Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
Experimental: 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.	Drug: Placebo Single dose of placebo will be provided. Drug: Vofopitant Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules. Drug: Lamotrigine Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
Experimental: 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.	Drug: Placebo Single dose of placebo will be provided. Drug: Vofopitant Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules. Drug: Lamotrigine Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
Experimental: 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.	Drug: Placebo Single dose of placebo will be provided. Drug: Vofopitant Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules. Drug: Lamotrigine Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
Experimental: 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.	Drug: Placebo Single dose of placebo will be provided. Drug: Vofopitant Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules. Drug: Lamotrigine Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
Experimental: 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.	Drug: Placebo Single dose of placebo will be provided. Drug: Vofopitant Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules. Drug: Lamotrigine Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
Experimental: 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.	Drug: Placebo Single dose of placebo will be provided. Drug: Vofopitant Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules. Drug: Lamotrigine Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
Experimental: 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.	Drug: Placebo Single dose of placebo will be provided. Drug: Vofopitant Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules. Drug: Lamotrigine Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
Experimental: 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.	Drug: Placebo Single dose of placebo will be provided. Drug: Vofopitant Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules. Drug: Lamotrigine Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
Experimental: 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.	Drug: Placebo Single dose of placebo will be provided. Drug: Vofopitant Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules. Drug: Lamotrigine Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
Experimental: 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.	Drug: Placebo Single dose of placebo will be provided. Drug: Vofopitant Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules. Drug: Lamotrigine Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
Experimental: 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.	Drug: Placebo Single dose of placebo will be provided. Drug: Vofopitant Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules. Drug: Lamotrigine Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
Experimental: 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.	Drug: Placebo Single dose of placebo will be provided. Drug: Vofopitant Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules. Drug: Lamotrigine Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
Experimental: 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.	Drug: Placebo Single dose of placebo will be provided. Drug: Vofopitant Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules. Drug: Lamotrigine Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
Experimental: 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.	Drug: Placebo Single dose of placebo will be provided. Drug: Vofopitant Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules. Drug: Lamotrigine Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
Experimental: 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.	Drug: Placebo Single dose of placebo will be provided. Drug: Vofopitant Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules. Drug: Lamotrigine Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
Experimental: 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.	Drug: Placebo Single dose of placebo will be provided. Drug: Vofopitant Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules. Drug: Lamotrigine Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
Experimental: 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.	Drug: Placebo Single dose of placebo will be provided. Drug: Vofopitant Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules. Drug: Lamotrigine Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.

Outcome Measures

Primary Outcome Measures

Effect of the study treatments on Resting Motor Thresholds (rMT) [Within 24 hours]

Secondary Outcome Measures

The safety and tolerability of the combination of study treatments. [Within 24 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Goettingen	Niedersachsen	Germany	37075

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Publications

None provided.

Responsible Party:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00907985

Other Study ID Numbers:

112676

First Posted:

May 25, 2009

Last Update Posted:

Jul 21, 2017

Last Verified:

Jul 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Keywords provided by GlaxoSmithKline

Healthy Volunteer

Resting motor threshold (rMT)

Transcranial magnetic stimulation (TMS)

Additional relevant MeSH terms:

Bipolar Disorder

Lamotrigine

Vofopitant

Study Results

No Results Posted as of Jul 21, 2017