Single-Dose Escalation Study Followed by a Multiple-Dose Escalation Study of SKL24741 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

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
    

Intervention name(s): SKL24741; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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.; Sugar pill manufactured to mimic SKL24741
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment