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Chronic Graft Versus Host DiseasePhase 1NCT07726914

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

A Phase 1 study testing Belumosudil in people with Chronic Graft Versus Host Disease, run by Sanofi.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Chronic Graft Versus Host Disease
What is being tested?
Belumosudil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
No sites listed yet
Study dates
6 Aug 2026to 28 Sep 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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:
Show all 25Show fewer
  • 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.

Who cannot join

None listed.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

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

800-633-1610 ext. option 6

Contact-US@sanofi.com

About this study

Official title: 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.

Being tested
Belumosudil
Medical subject headings
Bronchiolitis Obliterans Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BelumosudilDrug

    Also called SAR445761, REZUROCK

    Pharmaceutical form:Tablet-Route of administration:Oral

  • BelumosudilDrug

    Also called SAR445761, REZUROCK

    Pharmaceutical form:Oral suspension-Route of administration:Oral

Study groups in NCT07726914
Study groupRoleWhat they receive
belumosudil tablet，then belumosudil oral suspensionExperimentalbelumosudil tablet in period 1, then belumosudil oral suspension in period 2.
Receives: Drug: Belumosudil
belumosudil oral suspension, then belumosudil tabletExperimentalbelumosudil oral suspension in period 1, then belumosudil tablet in period 2.
Receives: Drug: Belumosudil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUClast

    Area under the plasma concentration versus time curve until the time of last quantifiable concentration

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

  2. Cmax

    Maximum plasma concentration observed

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

Secondary outcomes (6)

  1. tmax

    Time to reach Cmax

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

  2. t1/2z

    Terminal half-life associated with the terminal slope (λz)

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

  3. tlag

    Interval between administration time and the sampling time preceding the first concentration above the limit of quantification

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

  4. AUC

    Area under the plasma concentration versus time curve extrapolated to infinity

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

  5. AUClast/AUC

    AUClast/AUC ratio

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

  6. λz

    slope of the regression line of the observed terminal phase of the concentration versus time curve

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2026
  2. Study start6 Aug 2026 (estimated)
  3. Primary completion28 Sep 2026 (estimated)
  4. Study completion28 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
58 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07726914
Sponsor's protocol ID
BEQ17937
Other IDs
BEQ17937, U1111-1281-0122
Status last verified
Jul 2026
First submitted
21 Jul 2026
Last updated
24 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Belumosudil in people with Chronic Graft Versus Host Disease, run by Sanofi.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trial Transparency email recommended (Toll free for US & Canada) (800-633-1610 ext. option 6, Contact-US@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUClast (time frame: Baseline (H0) to Day 3 (H48) for each of the 2 periods). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07726914.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.

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