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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

Description: Investigational drug
Type: Drug
Group Labels: 5

Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5


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 22

Secondary Outcomes

Description: Measured by Cmax - The maximum plasma concentration of BLZ945

Measure: Plasma Pharmacokinetics (PK) of BLZ945 - Cmax

Time: Day 1; up to Day 17

Description: 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 17

Description: Measured by AUC - Area under the curve of BLZ945

Measure: Plasma Pharmacokinetics (PK) of BLZ945 - AUC

Time: Day 1; up to Day 17

Description: Measured by T1/2 - The elimination half-life of BLZ945

Measure: Plasma Pharmacokinetics (PK) of BLZ945 - T1/2

Time: Day 1; up to Day 17

Description: Urine renal clearance (CLR) of BLZ945

Measure: Renal Clearance (CLR) of BLZ945

Time: Day 1; up to Day 7

Description: 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 17

Purpose: 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.



HPO Nodes


HPO: