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Report for Clinical Trial NCT02169973

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

An Open-Label Study to Investigate the Regional Brain Kinetics of the Positron Emission Tomography Ligand 11C-MK-3168 and the Blocking of the Retention of the Ligand in the Human Brain by JNJ-42165279

The purpose of the study is to measure the uptake, distribution, and clearance of 11C-MK-3168 by Positron Emission Tomography (PET) scan and to model the tissue specific kinetics of 11C-MK-3168 with the appropriate input function in human brain in Part A; to measure blocking of retention of 11C-MK-3168 at the estimated time to maximum plasma concentration after dosing (tmax) following each single oral doses of JNJ-42165279 and model the exposure/enzyme interaction of JNJ-42165279 in Part B; to measure the saturation of enzyme inhibition in the brain at steady state plasma concentrations of JNJ-42165279 (on Day 8) after 7 once-daily doses of JNJ-42165279 by conducting PET studies with 11C-MK-3168 at trough plasma concentrations on Day 2 in Part C.

NCT02169973 Healthy

2 Interventions

Name: JNJ-42165279

Description: Participants will receive oral suspension of JNJ-42165279 in Part B as single dose on Day 1 (100 mg) and on Day 8 (up to 250 mg); in Part C as once daily dose (up to 100 mg) from Day 1 to Day 7.

Type: Drug

Part B Part C

Name: 11C-MK-3168

Description: Participants will receive 11C-MK-3168 in the target range of 185 to 370 megabecquerel (MBq) intravenously (into a vein) before every positron emission tomography scan in Parts A, B, and C.

Type: Drug

Part A Part B Part C


Primary Outcomes

Description: Uptake, distribution, and clearance of 11C-MK-3168 in the brain and plasma of healthy male participants will be evaluated by PET scan and arterial sampling.

Measure: Part A: Compartmental Model of the Volume of Distribution of 11C-MK-3168 in Brain by Positron Emission Tomography (PET)

Time: Day 1

Description: Occupancy of the FAAH in brain by JNJ-42165279 will be evaluated by comparing the distribution volume of 11C-MK-3168 after single dose JNJ-42165279 to the distribution volume at baseline.

Measure: Part B: Dose Dependent Occupancy of Fatty Acid Amide Hydrolase (FAAH) After Single Dose of JNJ-42165279

Time: Up to 5 weeks

Description: Occupancy of FAAH in brain by JNJ-42165279 at steady state will be evaluated by comparing the distribution volume of 11C-MK-3168 at Tmax after single dose JNJ-42165279 and then at trough after dosing for seven days with JNJ-42165279 to the distribution volume prior to treatment.

Measure: Part C: Dose and Time Dependent Occupancy of FAAH After Repeat Dose of JNJ-42165279

Time: Upto 5 weeks

Secondary Outcomes

Description: Correlation between peripheral and central FAAH inhibitions in white blood cells by JNJ 42165279 will be measured.

Measure: Correlation Between Fatty Acid Amide Hydrolase (FAAH) Occupancy in Brain With Peripheral FAAH inhibition

Time: Postdose Day 1 and Day 8

Description: Effect of FAAH C385A polymorphism on the distribution volume of 11C-MK-3168 in human brain will be assessed.

Measure: Effect of FAAH C385A polymorphism on the distribution volume of 11C-MK-3168 in human brain

Time: Postdose Day 1 and Day 8

Description: Number of participants with adverse events will be reported as an assessment of safety and tolerability of 11C-MK-3168 and JNJ-42165279.

Measure: Number of participants with adverse events

Time: Up to 5 weeks

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment


There is one SNP

SNPs


1 C385A

Correlation between peripheral and central FAAH inhibitions in white blood cells by JNJ 42165279 will be measured.. Effect of FAAH C385A polymorphism on the distribution volume of 11C-MK-3168 in human brain. --- C385A ---

Effect of FAAH C385A polymorphism on the distribution volume of 11C-MK-3168 in human brain will be assessed.. Number of participants with adverse events. --- C385A ---



HPO Nodes