A Blinded, Placebo-Controlled, Randomized, Single Ascending Dose Study in Healthy Male Subjects to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-37822681
Completed
- Conditions
- psychosis10039628
- Registration Number
- NL-OMON30850
- Lead Sponsor
- Johnson & Johnson Pharmaceutical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
healthy male subjects between 18 - 55 years of age
BMI between 18 and 30 kg/m²
Exclusion Criteria
History of, or currently active, significant illness or medical disorder
History of epilepsy or fits or unexplained black-outs
Significant history of or current neurological disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>safety and tolerability, adverse events, changes in blood pressure, pulse rate,<br /><br>lab. safety data, 12-lead ECG and physical examination.<br /><br>pharmacokinetic blood and urine tests<br /><br>pharmacodynamic evaluations: prolactine concentration, adaptive tracking,<br /><br>Saccadic eye movements, smooth pursuit eye movement test, Bond and Lader VAS,<br /><br>Bowden VAS, body sway, tapping, and pEEG.</p><br>
- Secondary Outcome Measures
Name Time Method <p>N/A</p><br>