Assessing J147 for Alzheimer's in Healthy Volunteers
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|
- 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.
Vince & Associates Clinical Research, Inc.
Abrexa Pharmaceuticals, Inc.
- Iqvia Pty Ltd
|Martin Kankam, MD, PhD, MPH||Principal Investigator||Vince & Associates Clinical Research, Inc.|
|Martin Kankam, MD, PhD, MPHemail@example.com|
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
- Chen Q, Prior M, Dargusch R, Roberts A, Riek R, Eichmann C, Chiruta C, Akaishi T, Abe K, Maher P, Schubert D. A novel neurotrophic drug for cognitive enhancement and Alzheimer's disease. PLoS One. 2011;6(12):e27865. doi: 10.1371/journal.pone.0027865. Epub 2011 Dec 14.
- Prior M, Dargusch R, Ehren JL, Chiruta C, Schubert D. The neurotrophic compound J147 reverses cognitive impairment in aged Alzheimer's disease mice. Alzheimers Res Ther. 2013 May 14;5(3):25. doi: 10.1186/alzrt179. eCollection 2013.
- Currais A, Goldberg J, Farrokhi C, Chang M, Prior M, Dargusch R, Daugherty D, Armando A, Quehenberger O, Maher P, Schubert D. A comprehensive multiomics approach toward understanding the relationship between aging and dementia. Aging (Albany NY). 2015 Nov;7(11):937-55.
- Prior M, Goldberg J, Chiruta C, Farrokhi C, Kopynets M, Roberts AJ, Schubert D. Selecting for neurogenic potential as an alternative for Alzheimer's disease drug discovery. Alzheimers Dement. 2016 Jun;12(6):678-86. doi: 10.1016/j.jalz.2016.03.016. Epub 2016 May 2.
- Goldberg J, Currais A, Prior M, Fischer W, Chiruta C, Ratliff E, Daugherty D, Dargusch R, Finley K, Esparza-Molt PB, Cuezva JM, Maher P, Petrascheck M, Schubert D. The mitochondrial ATP synthase is a shared drug target for aging and dementia. Aging Cell. 2018 Apr;17(2). doi: 10.1111/acel.12715. Epub 2018 Jan 7.