SNPMiner Trials (Home Page)
Report for Mutation D13H
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 to Investigate the Safety, Tolerability, and Pharmacokinetics of XC101-D13H in Healthy Adult Subjects
This is a randomized, double-blind, placebo-controlled, parallel-group single ascending dose (SAD) study. There are 4 cohorts of 8 subjects (8 active and 2 placebo) planned for evaluation under fasting conditions. One of the planned dose levels will cross over after a washout period to receive the same single dose of XC101-D13H or placebo under fed conditions.
NCT04104399 Migraine Drug: XC101-D13H Drug: Placebo
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Single Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of XC101-D13H in Healthy Adult Subjects. --- D13H ---
Single Ascending Dose Study to Investigate the Safety and Pharmacokinetics of XC101-D13H in Healthy Adult Subjects This is a randomized, double-blind, placebo-controlled, parallel-group single ascending dose (SAD) study. --- D13H ---
One of the planned dose levels will cross over after a washout period to receive the same single dose of XC101-D13H or placebo under fed conditions. --- D13H ---
Adverse Events will be monitored throughout confinement in the clinic and through the 14-day follow-up visit.. Maximum plasma concentration [Cmax] of XC101-D13H. --- D13H ---
Blood samples will be collected pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours post-dose and the maximum observed concentration for XC101-D13H will be calculated.. Area under the curve [AUC] of XC101-D13H. --- D13H ---
Blood samples will be collected pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours post-dose and the maximum observed concentration for XC101-D13H will be calculated.. Area under the curve [AUC] of XC101-D13H. --- D13H --- --- D13H ---
Blood samples will be collected pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 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 XC101-D13H.. Time to reach maximum plasma concentration [Tmax] of XC101-D13H. --- D13H ---
Blood samples will be collected pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 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 XC101-D13H.. Time to reach maximum plasma concentration [Tmax] of XC101-D13H. --- D13H --- --- D13H ---
Blood samples will be collected pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours post-dose and the time to reach the maximum plasma concentration of XC101-D13H will be calculated.. Major Inclusion Criteria: - Healthy, adult, male or female of non childbearing potential only, 18-55 years of age, inclusive, at screening. --- D13H ---
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-doseSecondary Outcomes
Description: Blood samples will be collected pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours post-dose and the maximum observed concentration for XC101-D13H will be calculated.
Measure: Maximum plasma concentration [Cmax] of XC101-D13H Time: 48 hoursDescription: Blood samples will be collected pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 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 XC101-D13H.
Measure: Area under the curve [AUC] of XC101-D13H Time: 48 hoursDescription: Blood samples will be collected pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours post-dose and the time to reach the maximum plasma concentration of XC101-D13H will be calculated.
Measure: Time to reach maximum plasma concentration [Tmax] of XC101-D13H Time: 48 hours