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

Phase 1TerminatedNCT00907985

GlaxoSmithKline12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Bipolar Disorder

Interventions

PlaceboDRUG

Single dose of placebo will be provided.

VofopitantDRUG

Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.

LamotrigineDRUG

Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

GSK Investigational Site

Göttingen, Lower Saxony, Germany

Outcomes

Primary Outcomes

Effect of the study treatments on Resting Motor Thresholds (rMT)

Time frame: Within 24 hours

Secondary Outcomes

The safety and tolerability of the combination of study treatments.

Time frame: Within 24 hours

Data from ClinicalTrials.gov

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