Intervention: Belumosudil
Trial phase: Phase 1
ATC code: L04AA48
SMILES: CC(C)NC(=O)COc1cccc(-c2nc(Nc3ccc4[nH]ncc4c3)c3ccccc3n2)c1
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 22
Group description: Single-dose belumosudil 200 mg capsule (two 100-mg capsules) in the fed state
Eligibility criteria:
Inclusion Criteria:

To be eligible for study entry subjects has to satisfy all of the following criteria:

Healthy males
Aged 18 to 55 years of age
Good state of health (mentally and physically) as indicated by a comprehensive clinical assessment (detailed medical history and a complete physical examination), ECG, and laboratory investigations (hematology, coagulation, clinical chemistry and urinalysis)
Body mass index 18.0-30.0 kg/m^2, or if outside the range, considered not clinically significant by the Investigator
Willing and able to communicate and participate in the whole study
Provide written informed consent
Agree to use an adequate method of contraception for up to 90 days post discharge

Exclusion Criteria

Subjects are excluded from the study if one of more of the following statements is applicable:

Participated in a clinical research study within the previous 3 months
Study site employees, or immediate family members of a study site or sponsor employee
Had been previously enrolled in this study
History of any drug or alcohol abuse in the past 2 years
Regular alcohol consumption > 21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
Current smokers and those who had smoked within the last 12 months. A breath carbon monoxide (CO) reading of greater than 10 ppm at screening
Did not have suitable veins for multiple venepunctures/cannulation as assessed by the Investigator at screening
Clinically significant abnormal biochemistry, hematology, coagulation, or urinalysis as judged by the Investigator
Positive drugs of abuse test result or alcohol breath test
Positive hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody (Ab) or human immunodeficiency virus (HIV) results
History of any clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal (GI) disease that may have compromised the subject's safety or interfered with the objectives of the study as judged by the investigator

Subject had a history or presence of any of the following:

Active GI disease requiring therapy
Hepatic disease and/or alanine aminotransaminase (ALT) or aspartate aminotransaminase (AST) > 1.5 × upper limit of normal (ULN) at screening
Renal disease and/or serum creatinine > 1.5 × ULN at screening
Other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
QT interval corrected using Fridericia's formula (QTcF) > 450 msec at the screening or admission ECG
Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
Known sensitivity to ROCK2 inhibitor agents or to any of the constituents of the belumosudil formulation
Presence or history of clinically significant allergy requiring treatment, as judged by the Investigator. Hayfever is permitted unless it is active.
Donation or loss of > 400 mL of blood within the previous 3 months
Taking or had taken any prescribed or over-the-counter drug (other than 4 g per day paracetamol) or herbal remedies in the 14 days before IP administration
Fails to satisfy the Investigator's discretion of fitness to participate or for any other reason

Additional Restrictions

Abstain from alcohol during the 24 h prior to each admission until discharge from the clinic in each study period
Not to drink liquids or eat food containing grapefruit, cranberry, caffeine, or other xanthines from 24 hours prior to each admission until 48 hours post-dose
Refrain from eating food containing any seeds (e.g., poppy) for 48 hours before the screening visit and then from 48 h prior to each admission until discharge from the clinic for each study period
Not to take part in any unaccustomed strenuous exercise from 72 hours prior to the screening visit and then from 72 hours prior to admission until discharge from the study