Clinical trial NCT01358006: A Dose-Ranging Study of JNJ-40411813 in Healthy Male Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: JNJ-40411813
Positron Emission Tomography (PET)
Serotonin-2A (5-HT2A) receptor antagonist
Male Volunteers
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2011-05-23
Enrollment: 13
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

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.

Eligibility criteria: 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 exclusion criteria as specified in the protocol

Primary outcomes:
measure: 5-HT2A binding determined by Positron Emission Tomography (PET) scans
timeFrame: Up to 24 hours after study drug administration
Secondary outcomes:
measure: Plasma concentration of JNJ-40411813
timeFrame: Up to 2 days
measure: Adverse Events Reported
timeFrame: Up to 10 days after study drug administration
Other outcomes:
Locations:
city: Groningen
country: Netherlands
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References: