Healthy
Conditions
Keywords
JNJ-40411813, Positron Emission Tomography (PET), Serotonin-2A (5-HT2A) receptor antagonist, Male Volunteers
Brief summary
The purpose of this study is to characterize the 5-HT2A binding over the maximum feasible dose range of JNJ-40411813, to estimate the plasma concentration associated with 50% 5-HT2A binding, and to investigate the safety and tolerability of JNJ-40411813 in healthy male volunteers.
Detailed description
This will be an open-label (volunteers and study staff will know the identity of assigned treatment), dose-ranging study to determine 5-HT2A receptor engagement by JNJ-40411813 as a function of dose and time in healthy male volunteers. The study will consist of an eligibility screening examination, an open-label treatment period and a follow-up examination (approximately 10 days after dose administration, a follow-up examination will be performed). Initially, 4 volunteers (Cohort 1) will be included to determine 5-HT2A receptor occupancy following single dose administration of JNJ-40411813. Dependent on the results, doses for the remaining 8 volunteers (Cohort 2 and 3) will be selected to further characterize 5-HT2A receptor occupancy within the feasible dose range up to maximally 700 mg JNJ-40411813.The maximal study duration for a volunteer will be 6 weeks. In this study, \[11C\]-MDL 100,907 will be used as positron emission tomography (PET) ligand to investigate the concentration-related binding of 40411813 to the 5-HT2A receptor in the brain. JNJ-40411813 (200 mg to 700 mg) will be taken orally (by mouth). If multiple capsules have to be taken, the actual intake may be spread over a 15-minute period. Study drug will be administered to each volunteer just after completion of a meal and within 30 minutes after the start of the meal.
Interventions
DRUGJNJ-40411813
Cohort 1: Type=2 to 3, unit=mg, number=200 to 300, form=capsule, route=oral use.Capsule(s) taken in the fed state Capsule(s) taken in the fed state.
Sponsors
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Have a body mass index (BMI) between 18 and 30 kg/m2, inclusive * Willing to adhere to the prohibitions and restrictions specified in this protocol * Volunteers must sign an informed consent to document that they understand the purpose of and procedures required for the study and are willing to participate in the study
Exclusion criteria
* Have abnormal values for clinical laboratory tests, clinically significant abnormal physical examination findings, vital signs, or 12-lead Electrocardiograms (ECGs) performed at screening considered to be of clinical significance to the Investigator * Have Significant history of or current significant medical illness that the Investigator considers should exclude the volunteer * Have known allergies, hypersensitivity, or intolerance to JNJ-40411813, its excipients, or to the PET ligand used in the study * Have significant history of psychiatric or neurological illness in first-degree relatives * Been exposed to ionizing radiation as a volunteer (including diagnostic procedures) * Presence of other
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5-HT2A binding determined by Positron Emission Tomography (PET) scans | Up to 24 hours after study drug administration |
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentration of JNJ-40411813 | Up to 2 days |
| Adverse Events Reported | Up to 10 days after study drug administration |
Countries
Netherlands
Outcome results
None listed