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

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: 18F-JNJ-64326067

Study type

Interventional

Funder types

Industry

Identifiers

NCT03581916

CR108426

64326067EDI1001 (Other Identifier)

Details and patient eligibility

About

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

Enrollment

6 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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)