Status:
COMPLETED
Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of J147
Lead Sponsor:
Abrexa Pharmaceuticals, Inc.
Collaborating Sponsors:
Iqvia Pty Ltd
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief Summary
This Phase I clinical study is a randomized, double-blind, placebo-controlled, parallel-design study to thoroughly assess the safety profile and PK properties of J147 in healthy subjects. The study wi...
Detailed Description
This Phase I clinical study is a randomized, double-blind, placebo-controlled, parallel-design study to thoroughly assess the safety profile and PK properties of J147 in healthy subjects and to perfor...
Eligibility Criteria
Inclusion
- Provide voluntarily agreement to participate in this study and signs an IRB/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 of signing the informed consent; OR, Healthy male and female subjects, between 60 to 85 years of age, inclusive, at the time of signing the informed consent
- If male, subjects with partners of child bearing potential must be practicing abstinence, part of an abstinent life style or agree to use a highly effective contraception method during the intervention period and for at least 3 months after the 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 a highly effective method. Post coital methods of contraception are not permitted.
- If female, must not be pregnant, must not be lactating, and must be of non-childbearing potential (surgically sterile \[hysterectomy or bilateral tubal ligation\] or postmenopausal ≥ 1 year.
- Body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive, at screening with a weight of at least 50 kg
- Nonsmokers (or other nicotine use) as determined by history (no nicotine use over the past year) and by urine cotinine concentration (\< 200 ng/mL) at the screening visit and admission
Exclusion
- 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
Key Trial Info
Start Date :
January 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2020
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT03838185
Start Date
January 22 2019
End Date
February 1 2020
Last Update
September 3 2020
Active Locations (1)
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1
Vince & Associates Clinical Research, Inc.
Overland Park, Kansas, United States, 66206