Start: January 22, 2019
End: February 1, 2020
What Is This Study About?
This Phase I clinical study will assess the safety and pharmacokinetics of the experimental drug J147 in healthy adults. Researchers are investigating the drug as a potential treatment for Alzheimer's disease.
Do I Qualify To Participate in This Study?
- Healthy males age 18 to 50; healthy males and females age 60 to 85
- If male with a partner of childbearing potential, must practice abstinence or use a highly effective contraceptive method during the study and for 3 months after; must refrain from donating sperm
- If female, must not be pregnant or lactating, and must be of non-childbearing potential (surgically sterile or 1 year post menopause)
- Body mass index of 18 to 30, with a weight of at least 110 lbs
- Nonsmokers (or other nicotine use) for at least 1 year
Must NOT have:
- History or evidence of heart, endocrine, blood, immune, gastrointestinal, genital, urinary, or other body system disease
- History or evidence of disease or dysfunction in neurological or psychiatric system that is likely to affect study results
- Any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs
- Any concurrent disease or condition that would make the participant unsuitable for study participation
- Positive for hepatitis B surface antigen, hepatitis C antibody, or HIV antibodies
- Positive test for ethanol (alcohol) or cotinine (tobacco) at screening or admission
- Positive urine drug test (e.g., cocaine, amphetamines, barbiturates, opiates, benzodiazepines, cannabinoids) at screening or admission
- Is unwilling to avoid consumption of grapefruit, Seville oranges, or other products containing grapefruit or Seville oranges within 14 days of taking the study drug
- History of alcohol and/or illicit drug abuse in past year or is unwilling to avoid use of alcohol or alcohol-containing foods, medications, or beverages within 48 hours of admission until discharge from the clinical unit
- Has donated blood or blood products within 30 days of first dosing
- Requires treatment with any prescription drugs or over-the-counter medications, including vitamins (large doses), dietary supplements, or herbal medications, within 14 days of study medication (acetaminophen 1,000 mg per day and recommended daily doses of vitamins are permitted)
- Has received any known liver or kidney clearance altering agents (e.g., erythromycin, cimetidine, barbiturates, phenothiazines, or St. John's wort) within 30 days of study start
- Has used an investigational drug within 30 days of screening
- Hypersensitivity or allergies to J147, any of its components, or any drug within the same class
- Significant abnormal vital signs on physical exam or laboratory results
- Is considering or has scheduled any surgical procedure during study participation
- Requires a special diet or has a significant food allergy or intolerance (vegetarian diet may be permitted)
- Currently enrolled in another clinical study
- Evidence of cognitive decline that is greater than expected for participant's age or changes in level of independence in everyday life
Martin Kankam, MD, PhD, MPH
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Where Is This Study Located?
Vince & Associates Clinical Research, Inc.
Overland Park, KS 66206
Lead: Abrexa Pharmaceuticals, Inc.
Source: ClinicalTrials.gov ID: NCT03838185