Study Evaluating The Safety and Tolerability of HTC-867 in Healthy Japanese Subjects

Inclusion:

• Men aged 20 to 45 years inclusive at screening. Sexually active men must agree to use a medically acceptable form of contraception during the study and continue it for 12 weeks after test article administration.
• Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight ≥45 kg.

BMI is calculated by taking the subject's weight, in kilograms, divided by the square of the subject's height, in meters, at screening: BMI = Weight (kg)/[Height (m)]2.

• Healthy as determined by the investigator on the basis of screening evaluations.
• Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.
• Have a high probability for compliance with and completion of the study.

Exclusion criteria

Medical History

• Presence or history of any disorder that may prevent the successful completion of the study.
• Any unstable medical condition.
• History of seizures.
• History of cardiac disorders (other than hypertension) including but not limited to valvular disease, congestive heart failure, angina pectoris, myocardial infarction, or arrhythmia.
• Any significant cardiovascular disease, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
• Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article (eg, resection of liver, kidney, gallbladder, or gastrointestinal tract).
• Acute disease state (eg, nausea, vomiting, infection, fever, or diarrhea) within 7 days before study day 1).
• History of drug abuse within 1 year before study day 1.
• Admitted alcohol abuse or history of alcohol use that may interfere with the subject's ability to comply with the protocol requirements.

Physical and Laboratory Findings

• Clinically significant electrocardiogram (ECG) abnormalities.
• Any clinically important deviation from normal limits in physical examination findings, vital sign measurements, 12-lead ECGs, or clinical laboratory test results.
• Positive serologic findings for human immunodeficiency virus (HIV) antigen and antibodies, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibodies.
• Positive findings of urine drug screen (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates, and phencyclidine [PCP]).
• Troponin T or CK-MB levels above reference range at screening. Allergies and Adverse Drug Reactions
• History of any clinically important drug allergy (eg, relapsing dermatitis, drug hypersensitivity, drug allergy, hypersensitivity to ingredient in the test articles, angioedema).

Prohibited Treatments

• Use of any investigational drug within 90 days before study day 1 or prescription drug within 30 days before study day 1.
• Tobacco use or the consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or carbonated beverages) or alcoholic beverages within 72 hours before study day 1 until the end of the inpatient confinement period.
• Consumption of grapefruit or grapefruit-containing products within 72 hours before study day 1 until the end of the inpatient confinement period.
• Use of any over-the-counter drugs, including herbal supplements (except for the occasional use of vitamins ≤100% of the recommended daily allowance), within 14 days before study day 1 (St. John wort is prohibited within 30 days of study day 1).
• Donation of blood within 90 days before study day 1. Others
• Subjects deemed by the investigator to be inappropriate according to the inclusion criteria in the study and according to the screening examination.