MedTrace Logo

Putative Cognitive Enhancer VU319

NCT03220295 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2020-02-06

No results posted yet for this study

Summary

This is a safety study of the molecule VU319 to ascertain pharmacokinetic and pharmacodynamic data and test cognitive enhancement in healthy volunteers.

Conditions

Interventions

DRUG

Single Dose of VU319

Single dose of VU319

DRUG

Single Dose Placebo

Single dose of placebo

OTHER

Fed State

drug is given 30 minutes after a high fat breakfast

OTHER

Fasted State

drug is given after an overnight fast

DRUG

Dose Escalation of VU319

dose levels of the cohorts will be increased step wise

DRUG

Placebo Dose Escalation

dose levels of the cohorts will be increased step wise

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    collaborator OTHER

  • Vanderbilt University

    lead OTHER

Principal Investigators

  • Paul A Newhouse, MD · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-28
Primary Completion
2019-10-30
Completion
2019-10-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03220295 on ClinicalTrials.gov