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Completed

NCT Number: NCT05918614

A Study to Determine the Effect of 500 mg Oral Dose of KD025 in Healthy Male and Post-menopausal Female Subjects

The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of 500 mg oral BID dose 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 58 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 is 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 58 days

    Number of participants with adverse events and serious adverse events

Secondary outcomes

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

    Time frame: Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28

    Cmax 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 30 hours postdose on Days 1 and 28

    tmax, observed time to reach peak plasma concentration

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

    Time frame: Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28

    Cmin, Minimum or "trough" plasma concentration after its administration and just prior to the administration of a subsequent dose as determined from the concentration time cprofile

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

    Time frame: Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28

    AUC0 -τis area under the plasma concentration-time curve from predose (time 0) to end of dosing collection (30 hours)

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

    Time frame: Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28

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

  6. Accumulation ratio (R) of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]

    Time frame: Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28

    Accumulation ratio, determined as the ratio of Day 28 AUC divided by Day 1 AUC and as the ratio of Day 28 Cmax divided by Day 1 Cmax

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

    Time frame: Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28

    t1/2 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 Study to Examine the Safety, Tolerability, and Pharmacokinetics of 500 mg KD025 Administered Twice Daily in Healthy Male and Post-Menopausal Female Subjects

Important dates

Study start
2014
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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