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?
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
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?
Collaborator Sponsor
-
Vanderbilt University Medical Center
Source:
ClinicalTrials.gov ID:
NCT03220295