A Study to Investigate the Whole Body Distribution and Radiation Dosimetry of the Positron Emission Tomography Ligand Fluoride-18 (18F)-JNJ-64326067 in Healthy Participants



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 75
Updated:12/5/2018
Start Date:July 11, 2018
End Date:November 2, 2018

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An Open-Label Study to Investigate the Total Body Distribution and Radiation Dosimetry of the Positron Emission Tomography Ligand 18F-JNJ-64326067 in Healthy Subjects

The purpose of this study is to measure the whole-body distribution and radiation dosimetry
of 18F-JNJ-64326067 in healthy participants.


Inclusion Criteria:

- Otherwise healthy for their age group on the basis of physical examination, medical
history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening or
Day 1 predose. If there are abnormalities, they must be consistent with the age of the
study population. This determination must be recorded in the participant's source
documents and initialed by the investigator

- Otherwise healthy for their age group on the basis of clinical laboratory tests
performed at screening. If the results of the serum chemistry panel, hematology, or
urinalysis are outside the normal reference ranges, the participant may be included
only if the investigator judges the abnormalities or deviations from normal to be not
clinically significant or to be appropriate and reasonable for the population under
study. This determination must be recorded in the participant's source documents and
initialed by the investigator

- Women must be postmenopausal (must be documented by medical records or physician's
note). A postmenopausal state is defined as no menses for 12 months without an
alternative medical cause. A high follicle stimulating hormone (FSH) level at
screening (greater than [>] 40 International Units Per Liter/ milli International
Units Per milliLiter [IU/L) or mIU/mL]) in the postmenopausal range may be used to
confirm a postmenopausal state in women not using hormonal contraception or hormonal
replacement therapy, however in the absence of 12 months of amenorrhea, a single FSH
measurement is insufficient

- During the study and for a minimum of 1 spermatogenesis cycle (defined as
approximately 90 days) after receiving the last dose of study drug, a man:

(a) who is sexually active with a woman of childbearing potential and has not had
vasectomy must agree to use a barrier method of contraception (that is, condom). In
addition, their female partner should also use a highly effective method of birth
control (example, hormonal contraception) 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

- Willing and able to adhere to the prohibitions and restrictions specified for this
clinical study

Exclusion Criteria:

- Radiation exposure through prior participation in other research protocols or clinical
care in the last year in addition to the radiation exposure expected from
participation in this clinical study, such that radiation exposure exceeds the
effective dose of 50 milli sievert (mSv), which would be above the acceptable annual
limits established by the United State (US) Federal Guidelines

- History of or current significant medical illness including (but not limited to)
cardiac arrhythmias or other cardiac disease, hematological disease, bronchospastic
respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid
disease, Parkinson's disease, infection, epilepsy or fits or unexplained black outs,
or any other illness that the Investigator considers should exclude the participant

- Serology positive for hepatitis B surface antigen (HBsAg), hepatitis C virus
antibodies (HCV) or human immunodeficiency virus (HIV) antibodies at screening

- History of drug or alcohol use disorder according to Diagnostic and Statistical Manual
of Mental Disorders (5th edition) (DSM-5) criteria within 6 months before screening or
positive test result(s) for alcohol and/or drugs of abuse (opiates (including
methadone), cocaine, amphetamines, cannabinoids, barbiturates,
3,4-methylenedioxy-methamphetamine (MDMA) and benzodiazepines) at screening or
admission

- History of malignancy within 5 years before screening (exceptions are squamous and
basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy
that in the opinion of the investigator, with written concurrence with the sponsor's
medical monitor, is considered cured with minimal risk of recurrence)
We found this trial at
1
site
New Haven, Connecticut
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New Haven, CT
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