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

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

Overview

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.

Interventions

• Drug Belumosudil
  Pharmaceutical form:Tablet-Route of administration:Oral
• Drug Belumosudil
  Pharmaceutical form:Oral suspension-Route of administration:Oral

Primary outcome measures

• AUClast [Time frame: Baseline (H0) to Day 3 (H48) for each of the 2 periods]
• Cmax [Time frame: Baseline (H0) to Day 3 (H48) for each of the 2 periods]

Secondary outcome measures (6)

• tmax [Time frame: Baseline (H0) to Day 3 (H48) for each of the 2 periods]
• t1/2z [Time frame: Baseline (H0) to Day 3 (H48) for each of the 2 periods]
• tlag [Time frame: Baseline (H0) to Day 3 (H48) for each of the 2 periods]
• AUC [Time frame: Baseline (H0) to Day 3 (H48) for each of the 2 periods]
• AUClast/AUC [Time frame: Baseline (H0) to Day 3 (H48) for each of the 2 periods]
• λz [Time frame: Baseline (H0) to Day 3 (H48) for each of the 2 periods]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07726914 · BEQ17937 · BEQ17937 · U1111-1281-0122

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗