Healthy ControlsPhase 1NCT07531316
Safety and Tolerability Study of VVZ-2471 in Healthy Volunteers
A Phase 1 study testing VVZ-2471 for 14-day intervention in people with Healthy Controls, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The goal of this study is to do follow-up testing on the safety and tolerability of an experimental (not FDA approved) medication. This study is seeking non-illicit drug using adults to test the medication. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Controls
- What is being tested?
- VVZ-2471 for 14-day intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2026to 30 Dec 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must meet all of the following criteria to be eligible for the study:
- Demographics: Male or female, between 18 and 65 years of age.
- 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.
- Informed Consent: Able to understand study procedures, follow instructions, and provide written informed consent in the English language.
- Health Status: Be in generally good health based on medical history, physical exam, clinical laboratory values, vital signs, and ECG done during the screening period, as deemed by the Principal Investigator (PI) or designee.
- Vital Signs (Resting): Resting pulse between 55 and 95 bpm; Systolic Blood Pressure between 90-120 mmHg; Diastolic Blood Pressure between 50-80 mmHg.
Show all 18Show fewer
- Vital Signs (Orthostatic): A set of orthostatic vital signs completed during screening and on each study visit demonstrating a decrease in Systolic Blood Pressure< 20 mmHg and Diastolic Blood Pressure <10 mmHg upon standing.
- BMI: Body Mass Index between 18.5 and 35 kg/m².
- Toxicology: Urine drug test negative for non-prescribed substances and a breath (or oral fluid) alcohol screen negative during screening.
- Cardiac Safety: QTcF interval < 450 ms and ECG findings considered normal or not clinically significant at screening by the PI/designee.
- Laboratory Values: Clinical labs completed during screening must meet the following safety thresholds:
- Serum creatinine, AST, ALT, BUN: < 1.5 x Upper Limit of Normal (ULN)
- Platelet count: >140 x 10⁹/L
- INR: < 1.2
- PT/aPTT: < 1.2 x ULN
- Fibrinogen: > 175 mg/dL
- Female Participants: Must not be of childbearing potential. They must be either post-menopausal or surgically sterile. They must not be pregnant or breastfeeding.
- Male Participants: Male subjects of reproductive potential must use a highly effective contraceptive method from first dose through 90 days after the last dose and to refrain from sperm donation during the same period.
Who cannot join
- Participants meeting any of the following criteria will be excluded:
- Psychiatric \& Substance Use
- Psychosis and bipolar disorder: Any lifetime history of psychosis or bipolar disorder.
- Current Psychiatric Disorder: Current or recent (within the last year) DSM-5 diagnosis of any other psychiatric disorder that would make study participation unsafe, including but not limited to depressive disorders, trauma- or stress related disorders, and anxiety disorders that in the opinion of the investigator would make study participation unsafe.
- Substance Use Disorder: Current DSM-5 diagnosis (any severity) of an alcohol or drug use disorder, or use of illicit/non-prescribed substances within the last 12 months.
- o Note: Tobacco use disorder is not considered exclusionary.
Show all 20Show fewer
- Suicidality: Current or recent suicidal or homicidal ideation (C-SSRS "yes" answers on any questions) or a history of suicide attempt within the past 12 months.
- Medical \& Neurological
- Neurological Disorders: History of neurological disorders including epilepsy or a family history of epilepsy, intractable/complicated migraine syndromes, cluster headache syndrome, extrapyramidal/pyramidal disorders, cerebrovascular, or degenerative disorders.
- Seizure History: Any lifetime history of seizure.
- Traumatic Brain Injury (TBI): Lifetime history of brain injury with loss of consciousness > 30 minutes, Past-year brain injury with loss of consciousness < 30 minutes.
- Cardiovascular Conditions: History of heart failure, cardiomyopathy, sick sinus syndrome, second or third-degree AV block, myocardial infarction, pulmonary congestion, symptomatic/significant cardiac arrhythmia, or clinically significant abnormal conduction on baseline ECG.
- Bleeding \& Coagulation: Recent history (within 6 months) of clinically significant bleeding; or history of intracranial hemorrhage, subdural/epidural hematoma, hemorrhagic stroke, AVM, or bleeding diatheses.
- Systemic Disease: History of malignancy (cancer), or significant respiratory, gastrointestinal, renal, urological, reproductive, endocrine, dermatological, or metabolic disorders.11. Liver/Pancreas: Pancreatic or liver disease that currently requires medical treatment.
- 12. Positive HIV, HCV or HBC test results indicative of HIV infection or active hepatitis B or hepatitis C infection.
- Medications \& Interactions 13. CYP3A4 Interactions: Currently taking prescription/OTC drugs or supplements known to significantly inhibit CYP3A4 (e.g., clarithromycin, ketoconazole, ritonavir, grapefruit juice) or induce CYP3A4 (e.g., phenobarbital, rifampicin, St. John's Wort).
- 14. CNS Active Medications: Currently taking a 5-HT2AR or mGluR5 antagonist or other CNS active medications that may increase risk as deemed by the PI or designee (e.g., antidepressants, antipsychotics, mood stabilizers, anticonvulsants, opioids, CGRP antagonists, triptans, ergotamines, or anxiolytics).
- 15. Study Drug History: Any previous medically adverse reaction to a 5-HT2AR or mGluR5 antagonist.
- 16. Concurrent Trials: Participation in another clinical trial with study medication administration within 30 days prior to first dosing.
- Other 17. General Safety: Any current, uncontrolled clinically significant medical condition that would make study participation unsafe, as deemed by the PI or designee.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lori Keyser-Marcus, PhD contact
United States1 site, 1 recruiting
- Recruiting
VCU Institute for Drug and Alcohol Studies
Richmond, Virginia, 23219
Lori, Lakeyser@vcu.edu
About this study
The goal of this study is to do follow-up testing on the safety and tolerability of 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. This research is supported by and included in the NIH HEAL Initiative (https://heal.nih.gov/).
Read the detailed 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.
- Conditions
- Healthy Controls
- Being tested
- Placebo pills for 14-day intervention, VVZ-2471 for 14-day intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo pills for 14-day interventionDrug
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.
VVZ-2471 for 14-day interventionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo pills for 14-day intervention |
| VVZ-2471 | Experimental | Study Medication Receives: Drug: VVZ-2471 for 14-day intervention |
| Sentinel group (first 10 participants) | Other | The sentinel group group of 10 participants (2 placebo treated and 8 VVZ-2471 treated) will undergo PK testing at study day 7 which will be reviewed by the DSMB to ensure the PK parameters do not reach stopping criteria based on unbound exposure levels (Cmax: 39.75 ng/mL and AUC0-24: 410.82 ng h/mL). If the exposure levels do not reach stopping criteria, dosing may proceed in remaining participants. Receives: Drug: Placebo pills for 14-day intervention; Drug: VVZ-2471 for 14-day intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety-AE Data
Adverse event data will be compiled for VVZ-2471 and placebo cohorts and presented as summary statistics.
Measured: from baseline to end of 14 day treatment
Secondary outcomes (2)
Impulsivity-Commision Errors
Impulsivity as measured by commission errors divided by correct detections on the immediate memory task.
Measured: Time Frame: from baseline to end of 14 day treatment
Tolerability of VVZ-2471
Subjective participant-related medication effects as measured by a visual analog scale (VAS).
Measured: from baseline to end of 14 day treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start28 Aug 2026
- Primary completion20 Dec 2031 (estimated)
- Study completion30 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ControlsStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double-blind randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- F. Gerard Moeller, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07531316
- Sponsor's protocol ID
- HM20032717
- Other IDs
- 1UG3DA063353
- Status last verified
- Aug 2026
- First submitted
- 20 Jan 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability Study of VVZ-2471 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07531316
- Acronym / sponsor ID
- HM20032717
- Conditions
- Healthy Controls
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 28 Aug 2026 (actual)
- Primary completion
- 20 Dec 2031 (estimated)
- Study completion
- 30 Dec 2031 (estimated)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to do follow-up testing on the safety and tolerability of 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. This research is supported by and included in the NIH HEAL Initiative (https://heal.nih.gov/).
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- double-blind randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo pills for 14-day interventionPlacebo |
| VVZ-2471 | Experimental | Drug: VVZ-2471 for 14-day interventionStudy Medication |
| Sentinel group (first 10 participants) | Other | Drug: Placebo pills for 14-day intervention, Drug: VVZ-2471 for 14-day interventionThe sentinel group group of 10 participants (2 placebo treated and 8 VVZ-2471 treated) will undergo PK testing at study day 7 which will be reviewed by the DSMB to ensure the PK parameters do not reach stopping criteria based on unbound exposure levels (Cmax: 39.75 ng/mL and AUC0-24: 410.82 ng h/mL). If the exposure levels do not reach stopping criteria, dosing may proceed in remaining participants. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Demographics: Male or female, between 18 and 65 years of age.
- 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.
- Informed Consent: Able to understand study procedures, follow instructions, and provide written informed consent in the English language.
- Health Status: Be in generally good health based on medical history, physical exam, clinical laboratory values, vital signs, and ECG done during the screening period, as deemed by the Principal Investigator (PI) or designee.
- Vital Signs (Resting): Resting pulse between 55 and 95 bpm; Systolic Blood Pressure between 90-120 mmHg; Diastolic Blood Pressure between 50-80 mmHg.
Key exclusion criteria (20 listed)
- Psychiatric \& Substance Use
- Psychosis and bipolar disorder: Any lifetime history of psychosis or bipolar disorder.
- Current Psychiatric Disorder: Current or recent (within the last year) DSM-5 diagnosis of any other psychiatric disorder that would make study participation unsafe, including but not limited to depressive disorders, trauma- or stress related disorders, and anxiety disorders that in the opinion of the investigator would make study participation unsafe.
- Substance Use Disorder: Current DSM-5 diagnosis (any severity) of an alcohol or drug use disorder, or use of illicit/non-prescribed substances within the last 12 months.
- o Note: Tobacco use disorder is not considered exclusionary.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo pills for 14-day interventionSubjects 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. | Drug | Placebo, Sentinel group (first 10 participants) |
| VVZ-2471 for 14-day intervention100 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. | Drug | Sentinel group (first 10 participants), VVZ-2471 |
Primary outcome
Safety-AE Data
Time frame: from baseline to end of 14 day treatment
Adverse event data will be compiled for VVZ-2471 and placebo cohorts and presented as summary statistics.
2 secondary outcomes
Impulsivity-Commision Errors
Time frame: Time Frame: from baseline to end of 14 day treatment
Tolerability of VVZ-2471
Time frame: from baseline to end of 14 day treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Healthy Controls
RecruitingPhase 2
Hematopoietic Stem Cell Mobilization in Idiopathic CD4 Lymphocytopenia Patients and Healthy Controls for the Study of T Cell Maturation and Trafficking in Murine Models
Idiopathic CD4-Positive, T-Lymphocytopenia
Not yet recruitingPhase 1
A Clinical Trial of MK-6916 in Participants With Moderate and Severe Kidney Disease Compared to Healthy Controls (MK-6916-013)
Healthy, Renal Impairment
RecruitingObservational study
Comparison of Individuals With Primary Ciliary Dyskinesia and Healthy Controls
Primary Ciliary Dyskinesia (PCD)
Active, not recruitingObservational study
SCIVAX: Biomarkers of Immune Dysfunction and Vaccine Responsiveness in Chronic SCI
Spinal Cord Injuries, Traumatic Spinal Cord Injury
Recruiting
Motor Learning in Health and Movement Disorders: Role of Physical Activity and Advanced Devices
Healthy Individuals (Controls), Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lori Keyser-Marcus, PhD contact
F. Gerard Moeller, MD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VVZ-2471 for 14-day intervention in people with Healthy Controls, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tiffany Pignatello, FNP (804-828-3686, study4u@vcu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety-AE Data (time frame: from baseline to end of 14 day treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.