Clinical trial NCT03693391: A Study to Investigate Alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic Acid (AMPA Gamma 8) Receptor Occupancy of JNJ-64140284 With Newly Developed Transmembrane AMPA Receptor Regulatory Protein (TARP)-Gamma 8 Positron Emission Tomography (PET) [18F]JNJ-64511070 in Healthy Men
Official title: An Open-Label Study to Investigate the AMPAɣ8 Receptor Occupancy of JNJ-64140284 With the Newly Developed TARP-γ8 PET Tracer [18F]JNJ-64511070 in Healthy Men
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2018-10-03
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to measure the blocking of \[18F\]JNJ-64511070 binding in the brain at the time after administration of a drug when the maximum plasma concentration is reached; when the rate of absorption equals the rate of elimination (tmax) of JNJ-64140284 and determine the exposure/receptor interaction of JNJ-64140284 in healthy male participants following single oral dose administration of JNJ-64140284.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m\^2) inclusive (Body Mass Index \[BMI\] = weight/height\^2)
* Non-smoker (not smoked for 3 months prior to screening) or/and has not used nicotine -containing products (for example, nicotine patch) for 3 months prior to screening
* Is willing to allow the investigators to place an arterial catheter in the radial artery, is assessed via physical examination (Allen Test) to be a good candidate for arterial catheter placement
* Has no history or laboratory evidence of a coagulopathy. (for participants undergoing positron emission tomography \[PET\] scan only)
* During the study and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of study drug, in addition to the highly effective method of contraception, a man a) who is sexually active with a woman of childbearing potential and has not had vasectomy must agree to use a condom and their female partner should also use oral contraception or user independent method such as intrauterine device (IUD) or hormonal implant for at least the same duration; b) who is sexually active with a woman who is pregnant, must use a condom; c) must agree not to donate sperm

Exclusion Criteria:

* Exposed to greater than (\>)1 milliSievert (mSv) of ionizing radiation participating as a participant in research studies 12 months before the start of this study
* Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening. It is expected that laboratory values will generally be within the normal range for the laboratory, though minor deviations, which are not considered to be of clinical significance to the investigator are acceptable
* Clinically significant abnormal physical and neurological examination, vital signs or 12-lead electrocardiogram (ECG) at screening or admission
* History of or current significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, liver or renal disease or obstruction to urinary flow, infection, or any other condition that the Investigator considers significant should exclude the participant. History of epilepsy or fits or unexplained black-outs
* Serology positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies or human immunodeficiency virus (HIV) antibodies unless the participant has been successfully treated for HCV or HIV. Successful treatment should be confirmed by a negative ribonucleic acid (RNA) test for the virus

Primary outcomes:
measure: Total and Regional Brain Compartmental Kinetics for Volume of Distribution (V[t]) of 18FJNJ-64511070
timeFrame: Approximately up to 1 hour on Day 2
measure: Percentage of Alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA gamma 8) Receptor Occupancy
timeFrame: Approximately up to 1 hour on Day 2
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Approximately 6 weeks
measure: Change from Baseline in Electroencephalogram (EEG) Power at Day 2
timeFrame: Baseline and Day 2
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: