A Blinded, Placebo-Controlled, Randomized, Single Ascending Dose Study in Healthy Male Subjects to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-37822681

A Blinded, Placebo-Controlled, Randomized, Single Ascending Dose Study in Healthy Male Subjects to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-37822681 - N/A

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30850

Enrollment

Registered

2007-04-27

Start date

2007-05-31

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

psychosis

Interventions

Each subject will receive 3 doses of JNJ-37822681 and 1 placebo dose, randomized over 4 study periods. It is planned that the subjects will receive escalating doses of JNJ-37822681. The starting dos

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male subjects between 18 - 55 years of age BMI between 18 and 30 kg/m²

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
safety and tolerability, adverse events, changes in blood pressure, pulse rate, lab. safety data, 12-lead ECG and physical examination. pharmacokinetic blood and urine tests pharmacodynamic evaluations: prolactine concentration, adaptive tracking, Saccadic eye movements, smooth pursuit eye movement test, Bond and Lader VAS, Bowden VAS, body sway, tapping, and pEEG.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)