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Completed

NCT Number: NCT05918588

A Study to Determine the Effect of Multiple Oral Doses and Regimens of KD025 in Healthy Male and Post-menopausal Female Subjects

The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of multiple oral doses and regimens of KD025 in healthy male and post-menopausal female 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

Buffalo, New York, 14202, United States

About this study

Up to approximately 37 days including safety follow up period of 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.
  • Female who was not of reproductive potential.
  • 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

  • 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: 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: Up to approximately 37 days

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

Secondary outcomes

  1. Cmax of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]

    Time frame: Predose and multiple timepoints up to 48 hours postdose on Days 1 and 7

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

  2. tmax of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]

    Time frame: Predose and multiple timepoints up to 48 hours postdose on Days 1 and 7

    tmax is observed time to reach peak plasma concentration

  3. AUC0-24 of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]

    Time frame: Predose and multiple timepoints up to 48 hours postdose on Days 1 and 7

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

  4. AUCinf of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]

    Time frame: Predose and multiple timepoints up to 48 hours postdose on Days 1 and 7

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

  5. Cmin of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]

    Time frame: Predose and multiple timepoints up to 48 hours postdose on Days 1 and 7

    Cmin is minimum or "trough" plasma concentration after its administration and just prior to the administration of a subsequent dose as determined from the concentration time profile

  6. t1/2 of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]

    Time frame: Predose and multiple timepoints up to 48 hours postdose on Days 1 and 7

    t1/2 is terminal elimination half-life

Sponsors and collaborators

Lead sponsor

Kadmon, a Sanofi Company

Industry

Registry information

Official study title

A Phase 1, Placebo-Controlled, Double-Blind, Dose-Escalating Study to Examine the Safety and Tolerability of Multiple Doses of KD025 (Formerly Called SLX-2119) in Healthy Male and Post- Menopausal Female Subjects

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
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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