Not Yet RecruitingPhase 1

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

58 participantsStarted 2026-08-06

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 dia…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is testing whether a liquid suspension of belumosudil works the same way in the body as the tablet form — if I have trouble swallowing tablets due to my condition or treatment, is this something worth keeping an eye on for future options?
2Since this is a Phase 1 study focused on healthy adult males comparing how the drug is absorbed rather than treating chronic graft-versus-host disease directly, does that mean it wouldn't offer me any direct treatment benefit right now?
3The trial isn't recruiting yet — given where I am in my treatment journey, would waiting to see if this study opens up make sense, or should we focus on currently available options for my cGvHD first?
4This study is measuring blood concentration levels like AUClast and Cmax to check if the two forms of belumosudil behave the same — can you explain what that means for whether the liquid form might eventually be an option for patients like me who might need an alternative to tablets?
5Are there existing approved treatments for chronic graft-versus-host disease, including the tablet form of belumosudil, that I should consider now while this early-phase comparison study is still being set up?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

AUClast

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

Cmax

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

Trial details

NCT IDNCT07726914

SponsorSanofi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09-28

Contact for this trial

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

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

View on ClinicalTrials.gov More Chronic Graft Versus Host Disease trials