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

Bipolar Disorder Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00907985
• Other study ID #: 112676
• Status: Terminated
• Phase: Phase 1
• First received: May 7, 2009
• Last updated: July 18, 2017
• Start date: May 15, 2009
• Est. completion date: June 10, 2010

Study information

• Verified date: July 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: June 10, 2010
• Est. primary completion date: June 10, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

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

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Goettingen	Niedersachsen

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of the study treatments on Resting Motor Thresholds (rMT)		Within 24 hours
Secondary	The safety and tolerability of the combination of study treatments.		Within 24 hours

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
•   Results for study 112676 can be found on the GSK Clinical Study Register.