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Assessing J147 for Alzheimer's in Healthy Volunteers

Completed

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.

Minimum Age Maximum Age Gender Healthy Volunteers
18 Years 85 Years All Yes
January 22, 2019
February 1, 2020
64

  • 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

  • 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

J147 is a synthetic derivative of curcumin, a component of the curry spice turmeric. In this study participants will be randomly assigned to take either the study drug or a placebo in an escalating dose. Doses will first be given to younger participants after an 8-hour fast. Older participants will then receive doses that have been found to be safe in younger participants.

Name City State Zip Status Primary Contact
Vince & Associates Clinical Research, Inc.
Overland Park Kansas 66206

Abrexa Pharmaceuticals, Inc.

  • Iqvia Pty Ltd

Name Role Affiliation
Martin Kankam, MD, PhD, MPH Principal Investigator Vince & Associates Clinical Research, Inc.

Name Phone Email
Martin Kankam, MD, PhD, MPH 913-696-1601 mkankam@altasciences.com
Kaela Schellenberger 913-696-1601 kschellenberger@altasciences.com

NCT03838185

A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of J147 in Healthy Young Volunteers and Healthy Elderly Volunteers