An open label dose-ranging study in healthy male subjects to investigate the binding potential of JNJ-40411813 to serotonin 2A receptors in the central nervous system.

An open label dose-ranging study in healthy male subjects to investigate the binding potential of JNJ-40411813 to serotonin 2A receptors in the central nervous system. - Protocol 40411813EDI1008

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36262

Enrollment

Registered

2010-10-27

Start date

2010-10-29

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

mental disorder psychosis

Interventions

The study medication will be given once on Day 1. The blood samples, vital signs and ECG will done at screening, in the clinic and at the follow-up. Furthermore a [11C]-MDL100,907 PET scan will be d

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Male Age between 18-45 (inclusive) BMI between 18 and 30 kg/m^2 (inclusive)

Exclusion criteria

Exclusion criteria: Clinical significant abnormalities during medical research

Design outcomes

Primary

Measure	Time frame
To estimate the plasma concentration associated with 50% 5-HT2A binding. To determine the 5-HT2A binding within the maximal feasible dose range. To investigate if there is a change in plasma concentration-occupancy relation over time. To investigate the safety and tolerability of JNJ-40411813 in healthy male subjects.	—

Secondary

Measure	Time frame
Not applicable.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)