A Positron Emission Tomography (PET) Study to Investigate P2X7 Receptor Occupancy by JNJ-55308942 Using [18F]-JNJ-64413739

Healthy Clinical Trial

Official title:

An Open-label PET Study to Investigate P2X7 Receptor Occupancy by JNJ-55308942 Using [18F]-JNJ-64413739

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03437590
• Other study ID #: CR108439
• Secondary ID: 2017-004517-5555
• Status: Completed
• Phase: Phase 1
• Start date: March 15, 2018
• Est. completion date: October 19, 2018

Study information

• Verified date: January 2019
• Source: Janssen-Cilag International NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to measure the blocking of [18F]-JNJ-64413739 uptake in the brain at the time to reach maximum plasma concentration (Tmax) and at 24 hours postdose of JNJ-55308942 following a single dose of JNJ-55308942; and to model the exposure/receptor interaction of JNJ-55308942.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: October 19, 2018
• Est. primary completion date: October 19, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m^2) inclusive (BMI = weight/height^2)

• 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 and should not be allergic to local anesthetics for catheter placement

• During the study and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of study drug participants must agree not to donate sperm. If a participant is sexually active with a woman he should agree to the following: (a) If it concerns a woman of childbearing potential and the participant has not had a vasectomy, the participant must agree to use a condom and make sure his female partner is using a highly effective method of birth control during the study and for a minimum of 90 days after the last dose of study drug. (b) If it concerns a woman of nonchild bearing potential, who is pregnant or has been sterilized and the participant has not had a vasectomy, the participant must agree to use a condom for the given period. (c) If the participant has had a vasectomy, he should agree to use a condom when being sexually active with a woman of child bearing potential. Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies

• 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 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 Principal 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

• Participant has a QT corrected according to Fridericia's formula (QTcF) interval of >450 millisecond (msec) at Screening or prior to "baseline" on Day 1, or has a history of additional risk factors for torsades de pointes (example, heart failure, hypokalemia, family history of Long QT Syndrome)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• JNJ-55308942
JNJ-55308942 will be administered as oral solution.
• [18F]-JNJ-64413739
[18F]-JNJ-64413739 fluid for injection administered intravenously.

Locations

Country	Name	City	State
Belgium	UZ Leuven Gasthuisberg	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag International NV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parts 1 and Part 2: Percentage of P2X7 Receptor Occupancy	[18F]-JNJ-64413739 uptake in brain following a single dose of JNJ-55308942 at Tmax of JNJ-55308942 will be measured using PET scans obtained at pre and post treatment with [18F]-JNJ-64413739, to determine the receptor occupancy.	4 hours postdose (Tmax)
Primary	Part 2: Percentage of P2X7 Receptor Occupancy	[18F]-JNJ-64413739 uptake in brain following a single dose of JNJ-55308942 at 24 hours postdose will be measured using PET scans obtained at pre and post treatment with [18F]-JNJ-64413739, to determine the receptor occupancy.	24 hours postdose
Secondary	Part 1 and 2: 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 7 weeks (Part 1) and approximately 6 weeks (Part 2)