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Completed

NCT Number: NCT05918627

A Study to Determine the Effect of Multiple 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.

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Key information

Conditions

Immune System Disorder (Healthy Volunteer) Immune System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational site

Baltimore, Maryland, 21225, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Belumosudil mesylate

Drug

Pharmaceutical form: capsule; Route of administration: oral

Other names: SLx-2119, KD025, SAR445761

Placebo

Drug

Pharmaceutical form: capsule; Route of administration: oral

Primary outcomes

  1. Number of participants with adverse events and serious adverse events

    Time frame: Day 1 up to approximately 30 days after participant is treated with the last dose of study drug.

    Safety observations and measurements include AEs, safety laboratory tests, vital sign measurements, physical examinations, and ECGs.

Secondary outcomes

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

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

    Cmax is maximum plasma concentration determined directly from the concentration time profile

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

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

    tmax is observed time to reach peak plasma concentration

  3. AUC0-24 of SLx-2119 and its metabolites (SLx-2131 and SLx-3047)

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

    AUC0-24 is area under the plasma concentration-time curve from predose (time 0) to 24 hours Postdose

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

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

    AUCinf is area under the concentration-time curve from predose (time 0) extrapolated to Infinity

  5. t1/2 of SLx-2119 and its metabolites (SLx-2131 and SLx-3047)

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

    t1/2 is terminal elimination half-life

Sponsors and collaborators

Lead sponsor

Kadmon, a Sanofi Company

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jun 26, 2023
Registry last updated
Jun 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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