A Study to Investigate the Regional Brain Kinetics of the Positron Emission Tomography Ligand [18F]JNJ-64511070

An Open-Label Study to Investigate the Regional Brain Kinetics of the Positron Emission Tomography Ligand [18F]JNJ-64511070

The main purpose of the study is to measure the whole-body distribution and radiation dosimetry of [18F]JNJ-64511070 in healthy male participants by positron emission tomography (PET) (Part A); and to measure the uptake, binding, distribution, and washout of [18F]JNJ-64511070 in the brain of healthy male participants by PET and to model tissue specific kinetics of [18F]JNJ-64511070 with the appropriate arterial input function (IF) (Part B).

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: [18F]JNJ-64511070

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven Gasthuisberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m^2) inclusive
• Nonsmoker (not smoked for 3 months prior to screening)
• Is willing to allow the investigators to place an arterial catheter in the radial artery and is assessed via physical examination (Allen test) to be a good candidate for arterial catheter placement (Part B 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, 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 a highly effective method of birth control 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
• Participants must have signed an informed consent document indicating that they understand the purpose of, and procedures required for,the study and are willing to participate in the study and comply with the study procedures and restrictions

Exclusion Criteria:

• Exposed to greater than (>) 1 milliSievert (mSv) of ionizing radiation participating as a participant in research studies in the 12 months before the start of enrolment in this study
• Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or admission. 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 both 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, coagulation abnormalities, or other conditions that the Investigator considers should exclude the participant and preclude their ability to participate in study procedures. Participants with a history significant liver or renal disease, or difficulty in urination, which could affect the metabolism and elimination of the radiotracer or radiometabolites should be excluded. Participants with a history of epilepsy or fits or unexplained black-outs or loss of consciousness should also be excluded
• Serology positive for hepatitis B surface antigen (HBsAg), hepatitis C (HCV) antibodies or human immunodeficiency (HIV) antibodies unless the participant has been successfully treated for HCV or HIV. In such cases, the response should be confirmed with RNA testing for the relevant pathogen

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: [18F]JNJ-64511070; Participants will receive an intravenous (IV) bolus injection of [18F]JNJ-64511070 at a dose of 185 megaBecquerel (MBq) on Day 1 of Part A to investigate the total body biodistribution and measure the radiation dosimetry of [18F]JNJ-64511070.	Drug: [18F]JNJ-64511070; An IV injection of 185 MBq [18F]JNJ-64511070 will be administered.
Experimental: Part B: [18F]JNJ-64511070; Participants will receive an IV bolus injection of [18F]JNJ-64511070 at a dose of 185 MBq on Day 1 of Part B to measure the uptake, binding, distribution, and washout of [18F]JNJ-64511070 and to model the tissue specific kinetics of [18F]JNJ-64511070 in the human brain with the appropriate arterial IF.	Drug: [18F]JNJ-64511070; An IV injection of 185 MBq [18F]JNJ-64511070 will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A: Effective Radiation Dose Following Injection of [18F]JNJ-64511070	The tissue radioactivity will be measured per organ for up to 5 hours after injection of up to 185 megaBecquerel (MBq) of [18F]JNJ-64511070 and corrected for attenuation by computed tomography (CT) transmission scans using positron emission tomography (PET) /CT. These measurements will be used to estimate effective radiation dose per organ and total body.	Up to 5 hours on Day 1
Part B: Total and Regional Brain Compartmental Kinetics for Volume of Distribution of [18F]JNJ-64511070 in Brain	The Distribution of [18F]JNJ-64511070 in brain will be measured by PET/CT scans obtained from the time of injection for up to 120 minutes along with measurement of the tracer input function with arterial samples for intact tracer and metabolites to establish the total and regional compartmental kinetics and volume of distribution (V[t]) of [18F]JNJ-64511070.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events as a Measure of Safety and Tolerability	An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.	Approximately Up to 4 weeks

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC. Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2017
• Primary Completion (Actual): February 6, 2018
• Study Completion (Actual): February 6, 2018

Study Registration Dates

• First Submitted: August 31, 2017
• First Submitted That Met QC Criteria: August 31, 2017
• First Posted (Actual): September 1, 2017

Study Record Updates

• Last Update Posted (Actual): April 19, 2019
• Last Update Submitted That Met QC Criteria: April 18, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: CR108379; 2017-002262-47 (EudraCT Number); 64140284EDI1002 (Other Identifier: Janssen Research & Development, LLC)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No