SNPMiner Trials (Home Page)
Report for Mutation C385A
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There is one clinical trial.
Clinical Trials
1 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 Drug: JNJ-42165279 Drug: 11C-MK-3168
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 ---
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 1Description: 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 weeksDescription: 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 weeksSecondary 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 8Description: 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 8Description: 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