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

NCT05918627 | Completed Phase 1

• 2 other identifiers: SLx-2119-09-01U1111-1291-6021
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Immune System Disorder (Healthy Volunteer)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Cmax of SLx-2119 and its metabolites (SLx-2131 and SLx-3047)

  Predose and multiple timepoints up to 24 hours postdose on Day 1

• tmax of SLx-2119 and its metabolites (SLx-2131 and SLx-3047)

  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)

  Predose and multiple timepoints up to 24 hours postdose on Day 1

• AUCinf of SLx-2119 and its metabolites (SLx-2131 and SLx-3047)

  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)

  Predose and multiple timepoints up to 24 hours postdose on Day 1

Study Arms (6)

Dose level 1

EXPERIMENTAL

Single Oral Doses of 20 mg SLx-2119 or placebo on Day 1

Drug: Belumosudil mesylate; Drug: Placebo

Dose level 2

EXPERIMENTAL

Single Oral Doses of 40 mg SLx-2119 or placebo on Day 1

Drug: Belumosudil mesylate; Drug: Placebo

Dose level 3

EXPERIMENTAL

Single Oral Doses of 80 mg SLx-2119 or placebo on Day 1

Drug: Belumosudil mesylate; Drug: Placebo

Dose level 4

EXPERIMENTAL

Single Oral Doses of 160 mg SLx-2119 or placebo on Day 1

Drug: Belumosudil mesylate; Drug: Placebo

Dose level 5

EXPERIMENTAL

Single Oral Doses of 320 mg SLx-2119 or placebo on Day 1

Drug: Belumosudil mesylate; Drug: Placebo

Dose level 6

EXPERIMENTAL

Single Oral Doses of 640 mg SLx-2119 or placebo on Day 1

Drug: Belumosudil mesylate; Drug: Placebo

Interventions

Belumosudil mesylate DRUG

Pharmaceutical form: capsule; Route of administration: oral

Also known as: SLx-2119, KD025, SAR445761

Dose level 1; Dose level 2; Dose level 3; Dose level 4; Dose level 5; Dose level 6

Placebo DRUG

Pharmaceutical form: capsule; Route of administration: oral

Dose level 1; Dose level 2; Dose level 3; Dose level 4; Dose level 5; Dose level 6

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kadmon, a Sanofi Company: lead

Study Sites (1)

Investigational site

Baltimore, Maryland, 21225, United States

Location

MeSH Terms

Conditions

Immune System Diseases

Interventions

KD025

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: June 26, 2023
• Study Start: September 21, 2009
• Primary Completion: December 9, 2009
• Study Completion: December 9, 2009
• Last Updated: June 26, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)