Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of J147

Exclusion Criteria

• •Has clinically significant history or evidence of cardiovascular, endocrine, hematologic, immune, gastrointestinal, genitourinary or other body system disease as determined by an Investigator
• •Has clinically significant history or evidence of disease or dysfunction in neurological or psychiatric system that is likely to affect the results of the study in the opinion of an Investigator
• •Has any disorder that would interfere with the absorption, distribution, metabolism or excretion of drugs
• •Subject has any concurrent disease or condition that, in the opinion of the Principal Investigator, would make the subject unsuitable for participation in the clinical study
• •Has positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV) or human immunodeficiency virus (HIV) antibodies
• •Has a urine blood test for ethanol or cotinine at the screening visit or admission
• •Has a positive urine drug test (e.g., cocaine, amphetamines, barbiturates, opiates, benzodiazepines, cannabinoids) at the screening visit or admission
• •Females who are breastfeeding
• •Is unwilling to or has not avoided consumption of grapefruit, grapefruit juice, Seville oranges, Seville orange marmalade or other products containing grapefruit or Seville oranges within 14 days of dosing with study medication
• •Has history of alcohol and/or illicit drug abuse within 1 year of entry or is unwilling to avoid use of alcohol or alcohol-containing foods, medications or beverages, within 48 hours prior to admission until discharge from the clinical unit
• •Has donated blood (\> 500 mL) or blood products within 30 days prior to first day of dosing
• •Requires treatment with any medication, prescription or over-the-counter (OTC) medications (including vitamins \[mega doses\], dietary supplements or herbal medications), prescription medications within 14 days prior to administration of study medication. By exception, acetaminophen ≤ 1000 mg per day and vitamin products at recommended daily doses are permitted
• •Has received any known hepatic or renal clearance altering agents (e.g., erythromycin, cimetidine, barbiturates, phenothiazines or herbal/plant-derived preparations such as St. John's wort) for a period of 30 days prior to dosing
• •Has used an investigational drug within 30 days prior to screening
• •Has a history of hypersensitivity or allergies to J147, any components of formulated J147, or any drug within the same class; minor drug allergies to a drug in another drug class may be approved by an Investigator if not considered of clinical relevance
• •Has clinically significant abnormal vital signs, 12-lead ECGs, physical examination, clinical laboratory, or other safety variable, as judged by an Investigator
• •Is considering or has scheduled any surgical procedure during study participation
• •Requires a special diet or has a significant food allergy or intolerance; if the subject or patient is vegetarian, he or she may be enrolled at an Investigator's discretion
• •Is unable to understand the protocol requirements, instructions and study related restrictions, the nature, scope and possible consequences of the clinical study
• •Is unlikely to comply with the protocol requirements, instructions and study related restrictions; e.g., uncooperative attitude, inability to return for follow-up visits and improbability of completing the clinical study
• •Has previously been enrolled in this clinical study or is currently enrolled in another clinical study
• •For the elderly subjects, there must be no evidence of cognitive decline that has been greater than expected for age and no evidence of changes in their level of independence in everyday life.
• •Is judged by an Investigator or Sponsor to be inappropriate for the study