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

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

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

Study Overview

• Status: Completed
• Conditions: Immune System Disorder (Healthy Volunteer)
• Intervention / Treatment: Drug: Placebo; Drug: Belumosudil mesylate

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21225
      • Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose level 1; Single Oral Doses of 20 mg SLx-2119 or placebo on Day 1	Drug: Placebo; Pharmaceutical form: capsule; Route of administration: oral; Drug: Belumosudil mesylate; Pharmaceutical form: capsule; Route of administration: oral; Other Names: SLx-2119; KD025; SAR445761
Experimental: Dose level 2; Single Oral Doses of 40 mg SLx-2119 or placebo on Day 1	Drug: Placebo; Pharmaceutical form: capsule; Route of administration: oral; Drug: Belumosudil mesylate; Pharmaceutical form: capsule; Route of administration: oral; Other Names: SLx-2119; KD025; SAR445761
Experimental: Dose level 3; Single Oral Doses of 80 mg SLx-2119 or placebo on Day 1	Drug: Placebo; Pharmaceutical form: capsule; Route of administration: oral; Drug: Belumosudil mesylate; Pharmaceutical form: capsule; Route of administration: oral; Other Names: SLx-2119; KD025; SAR445761
Experimental: Dose level 4; Single Oral Doses of 160 mg SLx-2119 or placebo on Day 1	Drug: Placebo; Pharmaceutical form: capsule; Route of administration: oral; Drug: Belumosudil mesylate; Pharmaceutical form: capsule; Route of administration: oral; Other Names: SLx-2119; KD025; SAR445761
Experimental: Dose level 5; Single Oral Doses of 320 mg SLx-2119 or placebo on Day 1	Drug: Placebo; Pharmaceutical form: capsule; Route of administration: oral; Drug: Belumosudil mesylate; Pharmaceutical form: capsule; Route of administration: oral; Other Names: SLx-2119; KD025; SAR445761
Experimental: Dose level 6; Single Oral Doses of 640 mg SLx-2119 or placebo on Day 1	Drug: Placebo; Pharmaceutical form: capsule; Route of administration: oral; Drug: Belumosudil mesylate; Pharmaceutical form: capsule; Route of administration: oral; Other Names: SLx-2119; KD025; SAR445761

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kadmon, a Sanofi Company
• Investigators: Study Director: Clinical Sciences & Operations, Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2009
• Primary Completion (Actual): December 9, 2009
• Study Completion (Actual): December 9, 2009

Study Registration Dates

• First Submitted: June 15, 2023
• First Submitted That Met QC Criteria: June 15, 2023
• First Posted (Actual): June 26, 2023

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Belumosudil
• Other Study ID Numbers: SLx-2119-09-01; U1111-1291-6021 (Other Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org