Chronic Graft Versus Host Disease
Conditions
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.
Interventions
DRUGBelumosudil
Pharmaceutical form:Tablet-Route of administration:Oral
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUClast | Baseline (H0) to Day 3 (H48) for each of the 2 periods | Area under the plasma concentration versus time curve until the time of last quantifiable concentration |
| Cmax | Baseline (H0) to Day 3 (H48) for each of the 2 periods | Maximum plasma concentration observed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| tmax | Baseline (H0) to Day 3 (H48) for each of the 2 periods | Time to reach Cmax |
| t1/2z | Baseline (H0) to Day 3 (H48) for each of the 2 periods | Terminal half-life associated with the terminal slope (λz) |
| tlag | Baseline (H0) to Day 3 (H48) for each of the 2 periods | Interval between administration time and the sampling time preceding the first concentration above the limit of quantification |
| AUC | Baseline (H0) to Day 3 (H48) for each of the 2 periods | Area under the plasma concentration versus time curve extrapolated to infinity |
| AUClast/AUC | Baseline (H0) to Day 3 (H48) for each of the 2 periods | AUClast/AUC ratio |
| λz | Baseline (H0) to Day 3 (H48) for each of the 2 periods | slope of the regression line of the observed terminal phase of the concentration versus time curve |
Contacts
CONTACTTrial Transparency email recommended (Toll free for US & Canada)
Outcome results
None listed