Not yet recruitingNCT07726914ClinicalTrials.gov record

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

Chronic Graft Versus Host Disease

Ask WCR about this study Official registry record ↗

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type: Interventional
Phase: Phase 1
Age range: 18 years - 45 years
Sex eligible: Male
Healthy volunteers: Accepted
Participants: 58 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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 may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Random assignment
Masking: No masking

belumosudil tablet，then belumosudil oral suspension

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

Drug: Belumosudil

belumosudil oral suspension, then belumosudil tablet

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

Drug: Belumosudil

Belumosudil DRUG

Pharmaceutical form:Tablet-Route of administration:Oral

Belumosudil DRUG

Pharmaceutical form:Oral suspension-Route of administration:Oral

Prepare your questions