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

Sponsor
Kadmon, a Sanofi Company (Industry)
Overall Status
Completed
CT.gov ID
NCT05918627
Collaborator
(none)
32
Enrollment
1
Location
6
Arms
2.6
Actual Duration (Months)
12.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Belumosudil mesylate
  • Drug: Placebo
 Phase 1

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official 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
Actual Study Start Date :
Sep 21, 2009
Actual Primary Completion Date :
Dec 9, 2009
Actual Study Completion Date :
Dec 9, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dose level 1

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

Drug: Belumosudil mesylate
Pharmaceutical form: capsule; Route of administration: oral
Other Names:
  • SLx-2119
  • KD025
  • SAR445761

    • Drug: Placebo
    Pharmaceutical form: capsule; Route of administration: oral
    Experimental: Dose level 2

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

    Drug: Belumosudil mesylate
    Pharmaceutical form: capsule; Route of administration: oral
    Other Names:
  • SLx-2119
  • KD025
  • SAR445761

    • Drug: Placebo
    Pharmaceutical form: capsule; Route of administration: oral
    Experimental: Dose level 3

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

    Drug: Belumosudil mesylate
    Pharmaceutical form: capsule; Route of administration: oral
    Other Names:
  • SLx-2119
  • KD025
  • SAR445761

    • Drug: Placebo
    Pharmaceutical form: capsule; Route of administration: oral
    Experimental: Dose level 4

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

    Drug: Belumosudil mesylate
    Pharmaceutical form: capsule; Route of administration: oral
    Other Names:
  • SLx-2119
  • KD025
  • SAR445761

    • Drug: Placebo
    Pharmaceutical form: capsule; Route of administration: oral
    Experimental: Dose level 5

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

    Drug: Belumosudil mesylate
    Pharmaceutical form: capsule; Route of administration: oral
    Other Names:
  • SLx-2119
  • KD025
  • SAR445761

    • Drug: Placebo
    Pharmaceutical form: capsule; Route of administration: oral
    Experimental: Dose level 6

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

    Drug: Belumosudil mesylate
    Pharmaceutical form: capsule; Route of administration: oral
    Other Names:
  • SLx-2119
  • KD025
  • SAR445761

    • Drug: Placebo
    Pharmaceutical form: capsule; Route of administration: oral

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with adverse events and serious adverse events [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 Outcome Measures

    1. Cmax of SLx-2119 and its metabolites (SLx-2131 and SLx-3047) [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) [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) [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) [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) [Predose and multiple timepoints up to 24 hours postdose on Day 1]

      t1/2 is terminal elimination half-life

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Investigational site Baltimore Maryland United States 21225

    Sponsors and Collaborators

    • Kadmon, a Sanofi Company

    Investigators

    • Study Director: Clinical Sciences & Operations, Sanofi

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kadmon, a Sanofi Company
    ClinicalTrials.gov Identifier:
    NCT05918627
    Other Study ID Numbers:
    • SLx-2119-09-01
    • U1111-1291-6021
    First Posted:
    Jun 26, 2023
    Last Update Posted:
    Jun 26, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Immune System Diseases
    Belumosudil

    Study Results

    No Results Posted as of Jun 26, 2023