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
NCT00907985 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2017-07-21
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.
Conditions
Interventions
- DRUG
-
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.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials · GlaxoSmithKline
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2009-05-15
- Primary Completion
- 2010-06-10
- Completion
- 2010-06-10
Countries
- Germany
Study Locations
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