Skip to main content
U.S. flag

An official website of the United States government

Here's how you know

Here's how you know

Official websites use .gov
A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS
A lock (  ) or https:// means you've safely connected to the .gov website. Share sensitive information only on official, secure websites.

Find more clinical trials

VU319 in Healthy Adult Volunteers

Start: July 2017
End: October 2019
Enrollment: 52

What Is This Study About?

This Phase I trial of the experimental drug VU319, developed to improve cognitive function in people with Alzheimers, will study its effects in healthy adults.

Do I Qualify To Participate in This Study?

Minimum Age: 18 Years

Maximum Age: 55 Years

Must have:

  • Body mass index of 18 to 32 kg/m2
  • Negative tests for Hepatitis B, Hepatitis C, HIV, and syphilis
  • Nonsmoker for at least 6 months (no smoking cessation drugs)
  • Negative screen for alcohol and drugs of abuse at screening and admission
  • If female, no child-bearing potential
  • If male, must be infertile or agree to use contraception
  • Participants must agree to the following:
    • No vaccinations within 21 days prior and through Day 7 after discharge
    • No nonprescription drugs, including vitamins, antacids, and supplements within 7 days prior to admission and 7 days after discharge (low doses of acetaminophen and ibuprofen allowed 48 hours after)
    • No nicotine-containing products from screening through 48 hours after discharge
    • No alcohol for 48 hours prior to admission and 48 hours after discharge
    • No grapefruit within 7 days prior to admission and through 24 hours after discharge
    • No caffeinated drinks from admission to discharge
    • No food or drink for 8 hours before and 4 hours after dosing 
    • Eat the high-fat standard breakfast 30 minutes pre-dose in Food Effect Cohort

Must NOT have:

  • Significant abnormalities on lab tests or physical/neurological exams
  • Significant previous or ongoing disease or disorder, including heart disease; high blood pressure; cancer; diabetes; liver disease; endocrine, metabolic, respiratory, kidney, gastrointestinal, dermatological, or blood disorders; and psychiatric or cognitive disorders
  • Acute gastrointestinal symptoms, such as nausea, vomiting, and diarrhea at screening or admission
  • History of abuse or misuse of alcohol, drugs, or other substances
  • Current or previous use of illegal drugs or amphetamines (occasional past use of cannabis is allowed if abstinent for past 3 months)
  • More than 21 units of alcohol per week or unwillingness to stop for study duration
  • Use of medication within 14 days of admission that may affect participation or use of any medication that needs continued during the study
  • Use of prescribed centrally active or psychoactive agents within 28 days
  • Use of any investigational medication within past 3 months
  • Participation in more than 2 clinical trials within past 12 months
  • Blood donation in past 3 months
  • History of severe allergies or multiple adverse drug reactions
  • Any condition that affects the ability to communicate with the investigator

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

Need Help?

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?

Who Sponsors This Study?

Lead: Vanderbilt University

Collaborator Sponsor

  • Vanderbilt University Medical Center

Source: ClinicalTrials.gov ID: NCT03220295

alzheimers.gov

An official website of the U.S. government, managed by the National Institute on Aging at the National Institutes of Health