Back to resultsA Study to Determine the Effect of Multiple Oral Doses and Regimens of KD025 in Healthy Male and Post-menopausal Female Subjects
Primary Purpose
Immune System Disorder (Healthy Volunteer)
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Belumosudil mesylate
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Immune System Disorder (Healthy Volunteer)
Eligibility Criteria
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.
Sites / Locations
- Investigational site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Arm Description
500 mg KD025 or placebo once daily (QD) for 7 days
800 mg KD025 or placebo QD for 7 days
500 mg KD025 or placebo twice daily (BID) for 7 days
1000 mg KD025 or placebo QD for 7 days
Outcomes
Primary Outcome Measures
Number of participants with adverse events and serious adverse events
Safety observations and measurements include AEs, safety laboratory tests, vital sign measurements, physical examinations, and ECGs.
Secondary Outcome Measures
Cmax of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]
Cmax is maximum plasma concentration determined directly from the concentration time profile
tmax of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]
tmax is observed time to reach peak plasma concentration
AUC0-24 of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]
AUC0-24 is area under the plasma concentration-time curve from predose (time 0) to 24 hours Postdose
AUCinf of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]
AUCinf is area under the concentration-time curve from predose (time 0) extrapolated to Infinity
Cmin of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]
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
t1/2 of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]
t1/2 is terminal elimination half-life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05918588
Brief Title
A Study to Determine the Effect of Multiple Oral Doses and Regimens of KD025 in Healthy Male and Post-menopausal Female Subjects
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 21, 2013 (Actual)
Primary Completion Date
March 6, 2014 (Actual)
Study Completion Date
March 6, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kadmon, a Sanofi Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
Up to approximately 37 days including safety follow up period of 30 days after participant is treated with the last dose of study drug.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune System Disorder (Healthy Volunteer)
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
500 mg KD025 or placebo once daily (QD) for 7 days
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
800 mg KD025 or placebo QD for 7 days
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
500 mg KD025 or placebo twice daily (BID) for 7 days
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
1000 mg KD025 or placebo QD for 7 days
Intervention Type
Drug
Intervention Name(s)
Belumosudil mesylate
Other Intervention Name(s)
KD025, SAR445761
Intervention Description
Pharmaceutical form: capsule; Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Pharmaceutical form: capsule; Route of administration: oral
Primary Outcome Measure Information:
Title
Number of participants with adverse events and serious adverse events
Description
Safety observations and measurements include AEs, safety laboratory tests, vital sign measurements, physical examinations, and ECGs.
Time Frame
Up to approximately 37 days
Secondary Outcome Measure Information:
Title
Cmax of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]
Description
Cmax is maximum plasma concentration determined directly from the concentration time profile
Time Frame
Predose and multiple timepoints up to 48 hours postdose on Days 1 and 7
Title
tmax of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]
Description
tmax is observed time to reach peak plasma concentration
Time Frame
Predose and multiple timepoints up to 48 hours postdose on Days 1 and 7
Title
AUC0-24 of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]
Description
AUC0-24 is area under the plasma concentration-time curve from predose (time 0) to 24 hours Postdose
Time Frame
Predose and multiple timepoints up to 48 hours postdose on Days 1 and 7
Title
AUCinf of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]
Description
AUCinf is area under the concentration-time curve from predose (time 0) extrapolated to Infinity
Time Frame
Predose and multiple timepoints up to 48 hours postdose on Days 1 and 7
Title
Cmin of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]
Description
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
Time Frame
Predose and multiple timepoints up to 48 hours postdose on Days 1 and 7
Title
t1/2 of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]
Description
t1/2 is terminal elimination half-life
Time Frame
Predose and multiple timepoints up to 48 hours postdose on Days 1 and 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
A Study to Determine the Effect of Multiple Oral Doses and Regimens of KD025 in Healthy Male and Post-menopausal Female Subjects
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