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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00907985

Enrollment

Registered

2009-05-25

Start date

2009-05-15

Completion date

2010-06-10

Last updated

2017-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

Keywords

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

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.

Interventions

DRUGPlacebo

Single dose of placebo will be provided.

DRUGVofopitant

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

DRUGLamotrigine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Effect of the study treatments on Resting Motor Thresholds (rMT)	Within 24 hours

Secondary

Measure	Time frame
The safety and tolerability of the combination of study treatments.	Within 24 hours

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026