Back to resultsA Study to Determine the Effect of 500 mg Oral Dose 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 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.
Sites / Locations
- Investigational site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
KD025
Placebo
Arm Description
500 mg KD025 administered orally twice daily (BID) for 28 days
Placebo administered orally BID for 28 days
Outcomes
Primary Outcome Measures
Number of participants with adverse events and serious adverse events
Number of participants with adverse events and serious adverse events
Secondary Outcome Measures
Cmax of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]
Cmax maximum plasma concentration determined directly from the concentration time profile
Tmax of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]
tmax, observed time to reach peak plasma concentration
Cmin of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]
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
AUC0 -τ of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]
AUC0 -τis area under the plasma concentration-time curve from predose (time 0) to end of dosing collection (30 hours)
AUCinf of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]
AUCinf, area under the concentration-time curve from predose (time 0) extrapolated to Infinity
Accumulation ratio (R) of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]
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
t1/2 of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]
t1/2 terminal elimination half-life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05918614
Brief Title
A Study to Determine the Effect of 500 mg Oral Dose of KD025 in Healthy Male and Post-menopausal Female Subjects
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
June 14, 2023
Overall Recruitment Status
Completed
Study Start Date
March 28, 2014 (Actual)
Primary Completion Date
June 7, 2014 (Actual)
Study Completion Date
June 7, 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 500 mg oral BID dose of KD025 in healthy male and post-menopausal female participants.
Detailed Description
Up to approximately 58 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
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KD025
Arm Type
Experimental
Arm Description
500 mg KD025 administered orally twice daily (BID) for 28 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered orally BID for 28 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
Number of participants with adverse events and serious adverse events
Time Frame
Up to approximately 58 days
Secondary Outcome Measure Information:
Title
Cmax of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]
Description
Cmax maximum plasma concentration determined directly from the concentration time profile
Time Frame
Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28
Title
Tmax of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]
Description
tmax, observed time to reach peak plasma concentration
Time Frame
Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28
Title
Cmin of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]
Description
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
Time Frame
Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28
Title
AUC0 -τ of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]
Description
AUC0 -τis area under the plasma concentration-time curve from predose (time 0) to end of dosing collection (30 hours)
Time Frame
Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28
Title
AUCinf of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]
Description
AUCinf, area under the concentration-time curve from predose (time 0) extrapolated to Infinity
Time Frame
Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28
Title
Accumulation ratio (R) of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]
Description
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
Time Frame
Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28
Title
t1/2 of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]
Description
t1/2 terminal elimination half-life
Time Frame
Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28
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 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.
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 500 mg Oral Dose of KD025 in Healthy Male and Post-menopausal Female Subjects
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