A Study to Determine the Effect of Multiple Oral Doses and Regimens of KD025 in Healthy Male and Post-menopausal Female Subjects

Sponsor

Kadmon, a Sanofi Company (Industry)

Overall Status

Completed

CT.gov ID

NCT05918588

Collaborator

(none)

Enrollment

Location

Arms

3.4

Actual Duration (Months)

9.3

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 oral doses and regimens of KD025 in healthy male and post-menopausal female participants.

Condition or Disease	Intervention/Treatment	Phase
Immune System Disorder (Healthy Volunteer)	Drug: Belumosudil mesylate Drug: Placebo	Phase 1

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.

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 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

Actual Study Start Date :

Nov 21, 2013

Actual Primary Completion Date :

Mar 6, 2014

Actual Study Completion Date :

Mar 6, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 500 mg KD025 or placebo once daily (QD) for 7 days	Drug: Belumosudil mesylate Pharmaceutical form: capsule; Route of administration: oral Other Names: KD025 SAR445761 Drug: Placebo Pharmaceutical form: capsule; Route of administration: oral
Experimental: Cohort 2 800 mg KD025 or placebo QD for 7 days	Drug: Belumosudil mesylate Pharmaceutical form: capsule; Route of administration: oral Other Names: KD025 SAR445761 Drug: Placebo Pharmaceutical form: capsule; Route of administration: oral
Experimental: Cohort 3 500 mg KD025 or placebo twice daily (BID) for 7 days	Drug: Belumosudil mesylate Pharmaceutical form: capsule; Route of administration: oral Other Names: KD025 SAR445761 Drug: Placebo Pharmaceutical form: capsule; Route of administration: oral
Experimental: Cohort 4 1000 mg KD025 or placebo QD for 7 days	Drug: Belumosudil mesylate Pharmaceutical form: capsule; Route of administration: oral Other Names: KD025 SAR445761 Drug: Placebo Pharmaceutical form: capsule; Route of administration: oral

Outcome Measures

Primary Outcome Measures

Number of participants with adverse events and serious adverse events [Up to approximately 37 days]
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)] [Predose and multiple timepoints up to 48 hours postdose on Days 1 and 7]
Cmax is maximum plasma concentration determined directly from the concentration time profile
tmax of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)] [Predose and multiple timepoints up to 48 hours postdose on Days 1 and 7]
tmax is observed time to reach peak plasma concentration
AUC0-24 of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)] [Predose and multiple timepoints up to 48 hours postdose on Days 1 and 7]
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)] [Predose and multiple timepoints up to 48 hours postdose on Days 1 and 7]
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)] [Predose and multiple timepoints up to 48 hours postdose on Days 1 and 7]
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)] [Predose and multiple timepoints up to 48 hours postdose on Days 1 and 7]
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.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigational site	Buffalo	New York	United States	14202

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:

NCT05918588

Other Study ID Numbers:

KD025-102
U1111-1290-9646

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