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

June 15, 2023 updated by: Kadmon, a Sanofi Company

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21225
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dose level 1
Single Oral Doses of 20 mg SLx-2119 or placebo on Day 1
Drug: Placebo
Pharmaceutical form: capsule; Route of administration: oral
Drug: Belumosudil mesylate
Pharmaceutical form: capsule; Route of administration: oral
Other Names:
  • SLx-2119
  • KD025
  • SAR445761
Experimental: Dose level 2
Single Oral Doses of 40 mg SLx-2119 or placebo on Day 1
Drug: Placebo
Pharmaceutical form: capsule; Route of administration: oral
Drug: Belumosudil mesylate
Pharmaceutical form: capsule; Route of administration: oral
Other Names:
  • SLx-2119
  • KD025
  • SAR445761
Experimental: Dose level 3
Single Oral Doses of 80 mg SLx-2119 or placebo on Day 1
Drug: Placebo
Pharmaceutical form: capsule; Route of administration: oral
Drug: Belumosudil mesylate
Pharmaceutical form: capsule; Route of administration: oral
Other Names:
  • SLx-2119
  • KD025
  • SAR445761
Experimental: Dose level 4
Single Oral Doses of 160 mg SLx-2119 or placebo on Day 1
Drug: Placebo
Pharmaceutical form: capsule; Route of administration: oral
Drug: Belumosudil mesylate
Pharmaceutical form: capsule; Route of administration: oral
Other Names:
  • SLx-2119
  • KD025
  • SAR445761
Experimental: Dose level 5
Single Oral Doses of 320 mg SLx-2119 or placebo on Day 1
Drug: Placebo
Pharmaceutical form: capsule; Route of administration: oral
Drug: Belumosudil mesylate
Pharmaceutical form: capsule; Route of administration: oral
Other Names:
  • SLx-2119
  • KD025
  • SAR445761
Experimental: Dose level 6
Single Oral Doses of 640 mg SLx-2119 or placebo on Day 1
Drug: Placebo
Pharmaceutical form: capsule; Route of administration: oral
Drug: Belumosudil mesylate
Pharmaceutical form: capsule; Route of administration: oral
Other Names:
  • SLx-2119
  • KD025
  • SAR445761

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Day 1 up to approximately 30 days after participant is treated with the last dose of study drug.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Predose and multiple timepoints up to 24 hours postdose on Day 1
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
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)
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
Predose and multiple timepoints up to 24 hours postdose on Day 1
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
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)
Time Frame: Predose and multiple timepoints up to 24 hours postdose on Day 1
t1/2 is terminal elimination half-life
Predose and multiple timepoints up to 24 hours postdose on Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kadmon, a Sanofi Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Sciences & Operations, Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 21, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 9, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 9, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 26, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SLx-2119-09-01
  • U1111-1291-6021 (Other Identifier: ICTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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