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
Verified date | July 2017 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Germany | GSK Investigational Site | Goettingen | Niedersachsen |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Germany,
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 |
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