Study to Compare the Plasma Concentration of Belumosudil Given as an Oral Suspension and as a Tablet to Healthy Adult Male Participants

An Open-label, Randomized, Phase 1, 2-treatment, 2-period, 2-sequence, Cross-over, Bioequivalence Study Comparing Belumosudil Oral Suspension (Test Formulation) With Belumosudil Tablet (Commercially Available Reference Formulation) in Healthy Adult Male Participants Under Fed Condition

The purpose of this open-label, randomized, cross-over, Phase 1, 2-treatment, 2-period, 2-sequence study is to assess the bioequivalence of belumosudil oral suspension compared with belumosudil tablet in healthy male participants aged 18 to 45 years, inclusive.

Study details include:

The study duration will be approximately 40 days. The treatment period will be up to 8 days. At least 3 days post-treatment follow-up period. end of study: 6±1 days from the last dose. The number of visits will be 3.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Graft Versus Host Disease
• Intervention / Treatment: Drug: Belumosudil; Drug: Belumosudil

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Trial Transparency email recommended (Toll free for US & Canada); Phone Number: option 6 800-633-1610; Email: contact-us@sanofi.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy male participant between 18 to 45 years of age, inclusive
• Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
• Body weight between 50.0 and 115.0 kg, inclusive, and BMI between 18.0 and 32.0 kg/m2, inclusive
• Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
• Capable of giving signed informed consent

Exclusion Criteria, participants are excluded from the study if any of the following criteria apply:

• Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness
• Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month).
• Blood donation (usually approximately 500 mL) within 2 months before inclusion
• Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in SBP ≥30 mmHg within 3 minutes when changing from supine to standing position
• Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician. Participants with known hypersensitivity to any component of the IMP formulation or allergic disease diagnosed and treated by a physician
• History or current presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis). Medically prescribed cannabis is not allowed
• Smoking regularly more than 5 cigarettes or equivalent in nicotine per week, unable to stop smoking (occasional smoker can be enrolled)
• Excessive consumption of beverages containing xanthine bases (more than 4 cups or glasses per day)
• Clinically significant history or presence of acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicaemia) within the 3 months or 90 days prior to screening
• Known or suspected malignancy, autoimmune disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status or any factor that would predispose participants to develop infection (eg, open skin lesion, recurrent issue related to poor dentition, perianal fissures, history of splenectomy, primary immunodeficiency)
• Any medication (including proton pump inhibitors, CYP3A inducers or strong and moderate CYP3A inhibitors, St John's Wort, or ginseng) within 14 days before study treatment administration or 5 half-lives, whichever is longer
• Use of any herbal medicines within 2 weeks before each IMP administration and up to the end of PK sampling following the IMP administration
• Any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion
• Current enrollment OR past participation in another investigational study in which an investigational intervention (eg, drug, vaccine, invasive device) was administered within the last 90 days or 5 half-lives whichever is longer, before inclusion in this clinical study
• Positive result on any of the following tests: HBs Ag, anti-HBc Ab (total or IgM), anti-HCV antibodies, anti-HIV 1 and 2 antibodies
• Confirmed positive result on urine drug screen (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates)
• Confirmed positive alcohol breath test
• Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: belumosudil tablet，then belumosudil oral suspension; belumosudil tablet in period 1, then belumosudil oral suspension in period 2.	Drug: Belumosudil; Pharmaceutical form:Tablet-Route of administration:Oral; Other Names: SAR445761; REZUROCK; Drug: Belumosudil; Pharmaceutical form:Oral suspension-Route of administration:Oral; Other Names: SAR445761; REZUROCK
Experimental: belumosudil oral suspension, then belumosudil tablet; belumosudil oral suspension in period 1, then belumosudil tablet in period 2.	Drug: Belumosudil; Pharmaceutical form:Tablet-Route of administration:Oral; Other Names: SAR445761; REZUROCK; Drug: Belumosudil; Pharmaceutical form:Oral suspension-Route of administration:Oral; Other Names: SAR445761; REZUROCK

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUClast	Area under the plasma concentration versus time curve until the time of last quantifiable concentration	Baseline (H0) to Day 3 (H48) for each of the 2 periods
Cmax	Maximum plasma concentration observed	Baseline (H0) to Day 3 (H48) for each of the 2 periods

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tmax	Time to reach Cmax	Baseline (H0) to Day 3 (H48) for each of the 2 periods
t1/2z	Terminal half-life associated with the terminal slope (λz)	Baseline (H0) to Day 3 (H48) for each of the 2 periods
tlag	Interval between administration time and the sampling time preceding the first concentration above the limit of quantification	Baseline (H0) to Day 3 (H48) for each of the 2 periods
AUC	Area under the plasma concentration versus time curve extrapolated to infinity	Baseline (H0) to Day 3 (H48) for each of the 2 periods
AUClast/AUC	AUClast/AUC ratio	Baseline (H0) to Day 3 (H48) for each of the 2 periods
λz	slope of the regression line of the observed terminal phase of the concentration versus time curve	Baseline (H0) to Day 3 (H48) for each of the 2 periods

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start (Estimated): August 6, 2026
• Primary Completion (Estimated): September 28, 2026
• Study Completion (Estimated): September 28, 2026

Study Registration Dates

• First Submitted: July 21, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organizing Pneumonia; Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Graft vs Host Disease; Bronchiolitis Obliterans Syndrome; belumosudil
• Other Study ID Numbers: BEQ17937 (Other Identifier: Sanofi Identifier); U1111-1281-0122 (Registry 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No