A Study to Determine the Effect of Multiple Oral Doses of SLx-2119 in Healthy Male Subjects

Study Overview
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Brief Summary
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The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of multiple doses of SLx-2119 in healthy male participants.

Detailed Description
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Duration per participants is Day 1 up to 30 days after participant is treated with the last dose of study drug.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Dose Escalating Study to Examine the Safety, Tolerability and Pharmacokinetic Profile of Single Oral Doses of SLx-2119 in Healthy Male Subjects

Conditions
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Immune System Disorder (Healthy Volunteer)

Intervention / Treatment
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* Drug: Belumosudil mesylate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy participants between the ages of 18 and 55 years, inclusive. Able to provide written informed consent prior to the performance of any study specific procedures. Body mass index (BMI) range of 19-30 kilogram per square meter (kg/m2), inclusive. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: Past or present disease that is judged by the investigator to have the potential to interfere with the study procedures, compromise safety, or affect the PK evaluations. Known sensitivity to Rho-associated coiled-coil containing serine/threonine protein kinases (ROCK2) inhibitor agents or to any of the constituents of the KD025 formulation. The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose level 1<br>Single Oral Doses of 20 mg SLx-2119 or placebo on Day 1 | Drug: Belumosudil mesylate<br>* Pharmaceutical form: capsule; Route of administration: oral<br>* Other names: SAR445761;Drug: Placebo<br>* Pharmaceutical form: capsule; Route of administration: oral<br>|
| Experimental: Dose level 2<br>Single Oral Doses of 40 mg SLx-2119 or placebo on Day 1 | Drug: Belumosudil mesylate<br>* Pharmaceutical form: capsule; Route of administration: oral<br>* Other names: SAR445761;Drug: Placebo<br>* Pharmaceutical form: capsule; Route of administration: oral<br>|
| Experimental: Dose level 3<br>Single Oral Doses of 80 mg SLx-2119 or placebo on Day 1 | Drug: Belumosudil mesylate<br>* Pharmaceutical form: capsule; Route of administration: oral<br>* Other names: SAR445761;Drug: Placebo<br>* Pharmaceutical form: capsule; Route of administration: oral<br>|
| Experimental: Dose level 4<br>Single Oral Doses of 160 mg SLx-2119 or placebo on Day 1 | Drug: Belumosudil mesylate<br>* Pharmaceutical form: capsule; Route of administration: oral<br>* Other names: SAR445761;Drug: Placebo<br>* Pharmaceutical form: capsule; Route of administration: oral<br>|
| Experimental: Dose level 5<br>Single Oral Doses of 320 mg SLx-2119 or placebo on Day 1 | Drug: Belumosudil mesylate<br>* Pharmaceutical form: capsule; Route of administration: oral<br>* Other names: SAR445761;Drug: Placebo<br>* Pharmaceutical form: capsule; Route of administration: oral<br>|
| Experimental: Dose level 6<br>Single Oral Doses of 640 mg SLx-2119 or placebo on Day 1 | Drug: Belumosudil mesylate<br>* Pharmaceutical form: capsule; Route of administration: oral<br>* Other names: SAR445761;Drug: Placebo<br>* Pharmaceutical form: capsule; Route of administration: oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events and serious adverse events | Safety observations and measurements include AEs, safety laboratory tests, vital sign measurements, physical examinations, and ECGs. | Day 1 up to approximately 30 days after participant is treated with the last dose of study drug. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of SLx-2119 and its metabolites (SLx-2131 and SLx-3047) | Cmax is maximum plasma concentration determined directly from the concentration time profile | Predose and multiple timepoints up to 24 hours postdose on Day 1 | 
| tmax of SLx-2119 and its metabolites (SLx-2131 and SLx-3047) | tmax is observed time to reach peak plasma concentration | Predose and multiple timepoints up to 24 hours postdose on Day 1 | 
| AUC0-24 of SLx-2119 and its metabolites (SLx-2131 and SLx-3047) | AUC0-24 is area under the plasma concentration-time curve from predose (time 0) to 24 hours Postdose | Predose and multiple timepoints up to 24 hours postdose on Day 1 | 
| AUCinf of SLx-2119 and its metabolites (SLx-2131 and SLx-3047) | AUCinf is area under the concentration-time curve from predose (time 0) extrapolated to Infinity | Predose and multiple timepoints up to 24 hours postdose on Day 1 | 
| t1/2 of SLx-2119 and its metabolites (SLx-2131 and SLx-3047) | t1/2 is terminal elimination half-life | Predose and multiple timepoints up to 24 hours postdose on Day 1 |