Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Healthy male subjects age ≥18 and ≤55 years
Body mass index ≥19 and ≤31 kg/m2, with minimum body weight of 50kg
No clinically significant findings in the medical history and physical examination, especially with regard to the respiratory, heart, immune system, pancreas, liver, bile and gastrointestinal systems
No clinically significant laboratory values and urinalysis, unless the investigator considers any abnormality to be clinically irrelevant;
Subjects with a partner of child-bearing potential must be willing to use an approved form of contraception with a failure rate of <1%. Subjects must be willing to use a condom during sexual intercourse whether or not their partner is of child-bearing potential from screening until 90 days after their final study visit.
Normal electrocardiogram (ECG), blood pressure, and heart rate, unless the investigator considers any abnormality to be clinically irrelevant
Informed consent must be obtained in writing for all subjects personally at enrollment

Exclusion Criteria:

Subjects with medically important events
Having 1st degree relative with coronary heart disease at age <60
Using of prescription drugs including but not limited to those known to interfere with metabolism of drugs within 30 days prior to dosing
Exposure to any other medication, including over-the-counter medications, herbal remedies and vitamins for at least 14 days before randomization (except paracetamol
Participation in another study with any investigational drug in 30 days or five half-lives (whichever is longer) preceding the study
Current smoker, defined as more than 10 cigarettes or equivalent per day before the beginning of the study (participants currently smoking ≤10 cigarettes daily and able to completely stop smoking during the study from screening until follow-up are eligible)
Symptoms of a clinically significant illness in the 3 months before the study
Presence or sequelae of respiratory, gastrointestinal, immune system, heart, liver or kidney disease, including asymptomatic unconjugated hyperbilirubinemia or asthma, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs
Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease
Hemorrhoids or anal diseases with regular or recent presence of blood in feces
History of immediate hypersensitivity to any medications or any food allergy, and acute phase of allergic rhinitis in the previous 2 weeks before randomization
Blood or plasma donation of more than 500 mL during the previous 2 months before randomization and/or more than 50 mL in the 2 weeks prior to screening, or plan to donate any additional blood for 12 weeks after completing the study
Subjects with a positive quantiFERON® test at screening or within 6 months prior to Day 1
Positive test for human immunodeficiency virus (HIV)
Positive test for hepatitis B (surface antigens HBs), or C (antibody HCs), unless caused by immunization
Positive urine drug screen within 1 year before randomization
Positive alcohol screen or active alcoholism
Mental condition rendering the subject incapable to understand the nature, scope, and possible consequences of the study
Subject has difficulty swallowing or is unable to swallow a tablet
Unlikely to comply with the clinical study protocol eg, uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study
Investigator, or any sub-investigator, research assistant, pharmacist, study coordinator, other staff directly involved in the conduct of the protocol, or first degree relative thereof
Subject requires anticoagulation treatment in the past 30 days
Subject with anemia of any kind
Subject with pancreatic abnormality of any kind, or elevated Lipase or Amylase >ULN