In this study, the binding of JNJ-40411813 to the brain cells and the concentration of JNJ-40411813 in the blood will be studied. Furthermore, the safety and tolerability of JNJ-40411813 will be investigated upon administration of JNJ-40411813,…
ID
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
Not applicable.
Background summary
JNJ-40411813 (study medication) is a new drug currently being developed for the
treatment of schizophrenia and other disorders of the central nervous systems
(CNS).
Study objective
In this study, the binding of JNJ-40411813 to the brain cells and the
concentration of JNJ-40411813 in the blood will be studied. Furthermore, the
safety and tolerability of JNJ-40411813 will be investigated upon
administration of JNJ-40411813, single dose.
Study design
An open label flexible dose study in healthy male subjects to investigate the
binding potential of JNJ-40411813 to serotonin 2A receptors in the central
nervous system.
Intervention
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 done twice per subject during
screening and on Day 1. Furthermore a MRI scan will be done at screening per
subject.
Study burden and risks
This is the 7th study with JNJ-40411813. The following side-effects were
observed for subjects who received a single dose of JNJ-40411813:
- CNS (central nervous system)-related side effects: Headache, dizziness,
sedation, euphoria (feeling very happy), fatigue, and blurred vision
- Gastrointestinal side effects: nausea, loose stools, and vomiting,
- Other: syncope (fainting), postural hypotension (drop in blood pressure when
standing up).
All of the mentioned side effects were mild to moderate (i.e. did not severely
affect daily functioning) and reversible. There were no serious adverse events
in that study and no treatment related changes were observed relating to blood
values, ECG, vital signs or physical examinations. No new adverse event was
observed in the subsequent single dose studies.
The adverse event profile of multiple dose studies with JNJ-40411813 was
generally consistent with that expected based on results of single-dose data.
The most common treatment-emergent adverse events were dizziness, fatigue and
headache. All adverse events were of mild or moderate severity. Moderate
adverse events observed in subjects receiving JNJ 40411813 included dizziness
(7 subjects), dyspepsia (1 subject), and blood triglycerides increased (1
subject).
Before JNJ-40411813 was given to humans for the first time, it has been
extensively tested in animals, according to regulatory guidelines. Based on the
data from the animal studies, no other side effects are expected than those
already reported with the planned doses in this study.
Turnhoutseweg 30
2340 Beerse
BE
Turnhoutseweg 30
2340 Beerse
BE
Listed location countries
Age
Inclusion criteria
Male
Age between 18-45 (inclusive)
BMI between 18 and 30 kg/m^2 (inclusive)
Exclusion criteria
Clinical significant abnormalities during medical research
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2010-022176-32-NL |
CCMO | NL34190.056.10 |