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Report for Clinical Trial NCT04104399

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

2 Interventions

Name: XC101-D13H

Description: XC101-D13H supplied as 0.4, 0.8, 1.6 or 3.2 mg dose, administered in capsules
Type: Drug
Group Labels: 1

XC130-A10H

Name: Placebo

Description: Placebo supplied as matching capsules
Type: Drug
Group Labels: 1

Placebo


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

Secondary 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 hours

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 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 hours

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 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

Purpose: Treatment

Allocation: Randomized

Sequential Assignment


There is one SNP

SNPs


1 D13H

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 ---



HPO Nodes