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Report for Clinical Trial NCT04066244
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
An Open-label, Adaptive Design Study in Patients With Amyotrophic Lateral Sclerosis (ALS) to Characterize Safety, Tolerability and Brain Microglia Response, as Measured by TSPO Binding, Following Multiple Doses of BLZ945 Using Positron Emission Tomography (PET) With the Radioligand [11C]-PBR28
It is an open label study to evaluate safety, tolerability and brain microglia response in ALS patients following multiple doses of BLZ945.
NCT04066244 Amyotrophic Lateral Sclerosis MeSH:Motor Neuron Disease Amyotrophic Lateral Sclerosis Sclerosis
HPO:Abnormal anterior horn cell morphology Amyotrophic lateral sclerosis
1 Interventions
Name: BLZ945
Primary Outcomes
Description: Volume of distribution (Vt) in different brain regions for each [11C]-PBR28 PET scan, and change after BLZ945 treatment, compared to baseline. Evaluate brain microglial reduction, as measured by reduction in TSPO binding following oral doses of BLZ945 in ALS subjects by using PET imaging with [11C]-PBR28.
Measure: Change from baseline in volume of distribution (Vt) in different brain regions for [11C]-PBR28 PET scan Time: Day -42, up to Day 22Secondary Outcomes
Description: Measured by Cmax - The maximum plasma concentration of BLZ945
Measure: Plasma Pharmacokinetics (PK) of BLZ945 - Cmax Time: Day 1; up to Day 17Description: Measured by Tmax - Time to Reach the Maximum Concentration After Drug Administration of BLZ945
Measure: Plasma Pharmacokinetics (PK) of BLZ945 - Tmax Time: Day 1; up to Day 17Description: Measured by AUC - Area under the curve of BLZ945
Measure: Plasma Pharmacokinetics (PK) of BLZ945 - AUC Time: Day 1; up to Day 17Description: Measured by T1/2 - The elimination half-life of BLZ945
Measure: Plasma Pharmacokinetics (PK) of BLZ945 - T1/2 Time: Day 1; up to Day 17Description: Urine renal clearance (CLR) of BLZ945
Measure: Renal Clearance (CLR) of BLZ945 Time: Day 1; up to Day 7Description: To assess the CYP2C8 pharmacogenomic-pharmacokinetic relationship; CYP2C8 genotyping and BLZ945 plasma PK parameters
Measure: CYP2C8 genotyping and BLZ945 plasma PK parameters Time: Day 1; up to Day 17Purpose: Treatment
Allocation: Non-Randomized
Sequential Assignment
There is one SNP
SNPs
1 rs6971
8. High-affinity binders (HAB) or mixed-affinity binders (MAB) to TSPO as evaluated by genotyping for the rs6971 polymorphism in the TSPO gene at the screening visit.