SNPMiner Trials by Shray Alag


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Report for Mutation A10H

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

There is one clinical trial.

Clinical Trials


1 A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single Ascending Dose Study Investigating the Safety, Tolerability, and Pharmacokinetics of XC130-A10H in Healthy Adult Subjects

This is a randomized, double-blind, placebo-controlled, parallel-group single ascending dose (SAD) study. Up to 5 cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. In each cohort, subjects will receive a single oral dose of XC130-A10H or matching placebo on Day 1. Safety, tolerability, and pharmacokinetics will be assessed throughout the study. Dose escalation will not take place until the Principal Investigator, Sponsor, and Medical Monitor have determined that adequate safety and tolerability from the previous cohorts have been demonstrated to permit proceeding to the next cohort.

NCT04043338 Parkinson's Disease Drug: XC130-A10H Drug: Placebo
MeSH: Parkinson Disease

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single Ascending Dose Study Investigating the Safety, Tolerability, and Pharmacokinetics of XC130-A10H in Healthy Adult Subjects. --- A10H ---

Single Ascending Dose Study Investigating the Safety, Tolerability, and PK of XC130-A10H in Healthy Adult Subjects This is a randomized, double-blind, placebo-controlled, parallel-group single ascending dose (SAD) study. --- A10H ---

In each cohort, subjects will receive a single oral dose of XC130-A10H or matching placebo on Day 1. Safety, tolerability, and pharmacokinetics will be assessed throughout the study. --- A10H ---

Blood pressure (systolic and diastolic) will be measured pre-dose and throughout the study at the time points specified and compared to baseline.. Maximum plasma concentration [Cmax] of XC13-A10H. --- A10H ---

Blood samples will be collected pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, and 48 hours post-dose and the maximum observed concentration for XC130-A10H and primary metabolite will be calculated.. Area under the curve [AUC] of XC130-A10H. --- A10H ---

Blood samples will be collected pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, and 48 hours post-dose and the maximum observed concentration for XC130-A10H and primary metabolite will be calculated.. Area under the curve [AUC] of XC130-A10H. --- A10H --- --- A10H ---

Blood samples will be collected pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, and 48 hours post-dose and the area under the concentration-time curve, from time 0 to the last observed non-zero concentration will be calculated for XC130-A10H and primary metabolite.. Time to reach the maximum plasma concentration [Tmax] of XC130-A10H. --- A10H ---

Blood samples will be collected pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, and 48 hours post-dose and the area under the concentration-time curve, from time 0 to the last observed non-zero concentration will be calculated for XC130-A10H and primary metabolite.. Time to reach the maximum plasma concentration [Tmax] of XC130-A10H. --- A10H --- --- A10H ---

Blood samples will be collected pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, and 48 hours post-dose and the time to reach the maximum plasma concentration of XC130-A10H and primary metabolite will be calculated.. Major Inclusion Criteria: - Healthy, adult, male or female of non-childbearing potential only, 18-75 years of age. --- A10H ---

In each cohort, subjects will receive a single oral dose of XC130-A10H or matching placebo on Day 1. Dose escalation will not take place until the Principal Investigator, Sponsor, and Medical Monitor have determined that adequate safety and tolerability from the previous cohorts have been demonstrated to permit proceeding to the next cohort. --- A10H ---

Blood samples will be collected through 48 hours post-dose for the PK assessment of XC130-A10H and the metabolites. --- A10H ---

Primary Outcomes

Description: Adverse Events will be monitored throughout confinement in the clinic and through the 14-day follow-up visit.

Measure: Incidence and severity of Adverse Events

Time: pre-dose through 14 days post-dose

Description: Blood pressure (systolic and diastolic) will be measured pre-dose and throughout the study at the time points specified and compared to baseline.

Measure: Changes from baseline in systolic and diastolic blood pressure

Time: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours

Secondary Outcomes

Description: Blood samples will be collected pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, and 48 hours post-dose and the maximum observed concentration for XC130-A10H and primary metabolite will be calculated.

Measure: Maximum plasma concentration [Cmax] of XC13-A10H

Time: 48 hours

Description: Blood samples will be collected pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, and 48 hours post-dose and the area under the concentration-time curve, from time 0 to the last observed non-zero concentration will be calculated for XC130-A10H and primary metabolite.

Measure: Area under the curve [AUC] of XC130-A10H

Time: 48 hours

Description: Blood samples will be collected pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, and 48 hours post-dose and the time to reach the maximum plasma concentration of XC130-A10H and primary metabolite will be calculated.

Measure: Time to reach the maximum plasma concentration [Tmax] of XC130-A10H

Time: 48 hours


HPO Nodes