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

NCT07726914 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: BEQ17937U1111-1281-0122
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Graft Versus Host Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• tmax

  Baseline (H0) to Day 3 (H48) for each of the 2 periods

• t1/2z

  Baseline (H0) to Day 3 (H48) for each of the 2 periods

• tlag

  Baseline (H0) to Day 3 (H48) for each of the 2 periods

• AUC

  Baseline (H0) to Day 3 (H48) for each of the 2 periods

• AUClast/AUC

  Baseline (H0) to Day 3 (H48) for each of the 2 periods

Study Arms (2)

belumosudil tablet，then belumosudil oral suspension

EXPERIMENTAL

belumosudil tablet in period 1, then belumosudil oral suspension in period 2.

Drug: Belumosudil

belumosudil oral suspension, then belumosudil tablet

EXPERIMENTAL

belumosudil oral suspension in period 1, then belumosudil tablet in period 2.

Drug: Belumosudil

Interventions

Belumosudil DRUG

Pharmaceutical form:Tablet-Route of administration:Oral

Also known as: SAR445761, REZUROCK

belumosudil oral suspension, then belumosudil tablet; belumosudil tablet，then belumosudil oral suspension

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).
• 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
• 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

Sponsors & Collaborators

• Sanofi: lead

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Interventions

belumosudil

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610; Contact-US@sanofi.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start (Estimated): August 6, 2026
• Primary Completion (Estimated): September 28, 2026
• Study Completion (Estimated): September 28, 2026
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share