Phase
Condition
Alzheimer's Disease
Dementia
Memory Loss
Treatment
N/AClinical Study ID
Ages 18-85 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Provide voluntarily agreement to participate in this study and signs anIRB/IEC-approved informed consent prior to performing any of the screening procedures
Healthy male subjects, between 18 to 50 years of age, inclusive, at the time ofsigning the informed consent; OR, Healthy male and female subjects, between 60 to 85years of age, inclusive, at the time of signing the informed consent
If male, subjects with partners of child bearing potential must be practicingabstinence, part of an abstinent life style or agree to use a highly effectivecontraception method during the intervention period and for at least 3 months afterthe last dose of study medication and refrain from donating sperm during this period.Because of the unacceptable failure rate of barrier (chemical and/or physical)methods, the barrier method of contraception must only be used in combination with ahighly effective method. Post coital methods of contraception are not permitted.
If female, must not be pregnant, must not be lactating, and must be ofnon-childbearing potential (surgically sterile [hysterectomy or bilateral tuballigation] or postmenopausal ≥ 1 year.
Body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive, at screening with aweight of at least 50 kg
Nonsmokers (or other nicotine use) as determined by history (no nicotine use over thepast year) and by urine cotinine concentration (< 200 ng/mL) at the screening visitand admission
Exclusion
Exclusion Criteria:
Has clinically significant history or evidence of cardiovascular, endocrine,hematologic, immune, gastrointestinal, genitourinary or other body system disease asdetermined by an Investigator
Has clinically significant history or evidence of disease or dysfunction inneurological or psychiatric system that is likely to affect the results of the studyin the opinion of an Investigator
Has any disorder that would interfere with the absorption, distribution, metabolism orexcretion of drugs
Subject has any concurrent disease or condition that, in the opinion of the PrincipalInvestigator, would make the subject unsuitable for participation in the clinicalstudy
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 orSeville oranges within 14 days of dosing with study medication
Has history of alcohol and/or illicit drug abuse within 1 year of entry or isunwilling to avoid use of alcohol or alcohol-containing foods, medications orbeverages, 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 ofdosing
Requires treatment with any medication, prescription or over-the-counter (OTC)medications (including vitamins [mega doses], dietary supplements or herbalmedications), prescription medications within 14 days prior to administration of studymedication. By exception, acetaminophen ≤ 1000 mg per day and vitamin products atrecommended 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 asSt. 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 formulatedJ147, or any drug within the same class; minor drug allergies to a drug in anotherdrug 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 thesubject or patient is vegetarian, he or she may be enrolled at an Investigator'sdiscretion
Is unable to understand the protocol requirements, instructions and study relatedrestrictions, the nature, scope and possible consequences of the clinical study
Is unlikely to comply with the protocol requirements, instructions and study relatedrestrictions; e.g., uncooperative attitude, inability to return for follow-up visitsand improbability of completing the clinical study
Has previously been enrolled in this clinical study or is currently enrolled inanother clinical study
For the elderly subjects, there must be no evidence of cognitive decline that has beengreater than expected for age and no evidence of changes in their level ofindependence in everyday life.
Is judged by an Investigator or Sponsor to be inappropriate for the study
Study Design
Study Description
Connect with a study center
Vince & Associates Clinical Research, Inc.
Overland Park, Kansas 66206
United StatesSite Not Available

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