Safety and Tolerability Study of VVZ-2471 in Healthy Volunteers
Virginia Commonwealth University
Summary
The goal of this study is to do follow-up safety testing and how well people are able tolerate an experimental (not FDA approved) medication . This study is seeking non-illicit drug using adults to test the medication. Results of this study will help us to develop future studies to test the medication with people who use substances.
Description
Adults between 18 and 65 years old will be recruited for the study. People who qualify for the study will be randomly (like the flip of a coin) assigned to take the study medication or placebo twice daily for 14 days. The study will include complete physical exams, bloodwork, ECGs of the heart, vital signs, psychological surveys and interviews, computer tasks, urine drug screens, completed over multiple study visits.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria Participants must meet all of the following criteria to be eligible for the study: 1. Demographics: Male or female, between 18 and 65 years of age. 2. High Impulsivity: Must demonstrate high impulsivity during the screening period, defined as an Immediate Memory Task (IMT) Commission Error by Correct Deletions (CE/CD) ratio \> 0.25. 3. Informed Consent: Able to understand study procedures, follow instructions, and provide written informed consent in the English language. 4. Health Status: Be in generally good health based on medical history, physical exam, clinical laborat…
Interventions
- DrugPlacebo pills for 14-day intervention
Subjects who are randomized to placebo will receive identical capsules to the study drug. During the 14-day intervention phase, participants will be instructed to take one capsule twice daily.
- DrugVVZ-2471 for 14-day intervention
100 mg/BID. Subjects who are randomized to VVZ-2471 will receive identical capsules to the placebo. During the 14-day intervention phase, participants will be instructed to take one capsule twice daily.
Location
- VCU Institute for Drug and Alcohol StudiesRichmond, Virginia