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

This study has been terminated.

(Slow recruitment; trial unlikely to reach completion)

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00907985

First received: May 7, 2009

Last updated: March 31, 2011

Last verified: March 2011

History of Changes

Purpose

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	Intervention	Phase
Healthy Subjects Healthy Volunteer Bipolar Disorder	Drug: Placebo Drug: Drug A (lamotrigine) Drug: Drug B (vofopitant)	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Lamotrigine

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Effect of the study treatments on Resting Motor Thresholds (rMT) [ Time Frame: Within 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The safety and tolerability of the combination of study treatments. [ Time Frame: Within 24 hours ] [ Designated as safety issue: Yes ]

Enrollment:	12
Study Start Date:	May 2009
Study Completion Date:	June 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo	Drug: Placebo Placebo for both Drug A and Drug B
Experimental: Drug A (lamotrigine)	Drug: Drug A (lamotrigine) 150mg/175mg
Experimental: Drug B (vofopitant)	Drug: Drug B (vofopitant) 10mg

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00907985

Locations

Germany
GSK Investigational Site
Goettingen, Niedersachsen, Germany, 37075

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00907985 History of Changes
Other Study ID Numbers:	112676
Study First Received:	May 7, 2009
Last Updated:	March 31, 2011
Health Authority:	Germany: Bundesinstitut für Arzneimittel und Medizinprodukte

Keywords provided by GlaxoSmithKline:

Healthy Volunteer
Resting motor threshold (rMT)
Transcranial magnetic stimulation (TMS)

Additional relevant MeSH terms:

Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Lamotrigine
Calcium Channel Blockers
Membrane Transport Modulators

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Anticonvulsants
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013

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