NCT04505397

Single-Dose Escalation Study Followed by a Multiple-Dose Escalation Study of SKL24741 in Healthy Subjects

A Phase 1, Randomized, Double-Blinded, Single-Dose Escalation Study Followed by a Multiple-Dose Escalation Study of SKL24741 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: SK Life Science, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study evaluates SKL24741 safety and tolerability in healthy subjects. Subjects will be randomized to receive oral doses of SKL24741 or placebo. This is a two-part, double-blinded, randomized study of SKL24741.

Detailed description

The study includes a sequential cohort design that is intended to optimize subject safety and assess tolerability, safety, and PK of SKL24741. In the single-dose escalation part of the study (Part A), tolerability, safety, and PK of SKL24741 will be assessed in healthy male subjects under fasting conditions. At an appropriate dose based on PK results, additional cohorts will be repeated with the subjects under fed conditions, in order to evaluate the magnitude on the disposition of SKL24741. To assess the gender effect on the disposition of SKL24741, female subjects will be treated at one dose level under fasting conditions. A preliminary formulation effect may be assessed in a cohort of subjects to compare the capsule versus tablet formulation on the disposition of SKL24741. Part A Primary Objective: To evaluate the safety and tolerability of single oral ascending doses of SKL24741 administered to healthy male subjects Part A Secondary Objectives: * To evaluate the PK of SKL24741 (R-enantiomer), SKL24742 (S-enantiomer) (if appropriate), and its possible metabolites (if deemed necessary) following administration of single oral ascending doses of SKL24741 administered to healthy male subjects * To assess the food effect on the PK of SKL24741 and SKL24742 (if appropriate) following administration of a single oral dose of SKL24741 administered to healthy male subjects * To assess the gender effect on the PK of SKL24741 and SKL24742 (if appropriate) following administration of a single oral dose of SKL24741 administered to healthy female subjects Part A Exploratory Objective: To assess the formulation effect on the PK of SKL24741 and SKL24742 (if appropriate) following administration of a single oral dose of SKL24741 administered to healthy male subjects Part B Primary Objective: To evaluate safety and tolerability of multiple oral ascending doses of SKL24741 administered for 14 days to healthy male subjects Part B Secondary Objective: To evaluate the PK of SKL24741, SKL24742 (if appropriate), and its possible metabolites (if deemed necessary) following administration of multiple oral ascending doses of SKL24741 administered to healthy male subjects

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	SKL24741	An inhibitor of voltage-gated sodium channels and a possible activator of Big Potassium channels. Administered as an oral dose in the form of a capsule or tablet.
DRUG	Placebo	Sugar pill manufactured to mimic SKL24741

Timeline

• Start date: 2020-02-13
• Primary completion: 2022-10-27
• Completion: 2022-10-27
• First posted: 2020-08-10
• Last updated: 2023-12-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study