Multiple Ascending Dose Putative Cognitive Enhancer VU319

NCT04051801 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: 190919
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability

  Incidence of Treatment-Emergent Adverse Events

  Changes in adverse events frequency from Baseline to 144 hours post last drug administration

Secondary Outcomes (17)

• Cognitive Battery - Critical Flicker Fusion (CFF)

  Baseline, 1 hours post last drug administration

• Cognitive Battery - Choice Reaction Time (CRT)

  Baseline, 1 hours post last drug administration

• Cognitive Battery - Spatial Selective Attention (Posner Task)

  Baseline, 1 hours post last drug administration

• Cognitive Battery - Continuous Performance Test (Conners)

  Baseline, 1 hours post last drug administration

• Cognitive Battery - Working Memory (N-Back Test)

  Baseline, 1 hours post last drug administration

Study Arms (6)

Dose Escalation of VU319 - Dose 1

EXPERIMENTAL

Drug: Dose Escalation of VU319; Drug: Dose Escalation of Placebo

Dose Escalation of Placebo - Dose 1

PLACEBO COMPARATOR

Drug: Dose Escalation of VU319; Drug: Dose Escalation of Placebo

Dose Escalation of VU319 - Dose 2

EXPERIMENTAL

Drug: Dose Escalation of VU319; Drug: Dose Escalation of Placebo

Dose Escalation of Placebo - Dose 2

PLACEBO COMPARATOR

Drug: Dose Escalation of VU319; Drug: Dose Escalation of Placebo

Dose Escalation of VU319 - Dose 3

EXPERIMENTAL

Drug: Dose Escalation of VU319; Drug: Dose Escalation of Placebo

Dose Escalation of Placebo - Dose 3

PLACEBO COMPARATOR

Drug: Dose Escalation of VU319; Drug: Dose Escalation of Placebo

Interventions

Dose Escalation of VU319 DRUG

dose levels of the cohorts will be increased step wise

Dose Escalation of Placebo - Dose 1; Dose Escalation of Placebo - Dose 2; Dose Escalation of Placebo - Dose 3; Dose Escalation of VU319 - Dose 1; Dose Escalation of VU319 - Dose 2; Dose Escalation of VU319 - Dose 3

Dose Escalation of Placebo DRUG

dose levels of the cohorts will be increased step wise

Dose Escalation of Placebo - Dose 1; Dose Escalation of Placebo - Dose 2; Dose Escalation of Placebo - Dose 3; Dose Escalation of VU319 - Dose 1; Dose Escalation of VU319 - Dose 2; Dose Escalation of VU319 - Dose 3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women aged 18 through 55 years, inclusive.
• Body mass index 18 through 32 kg/m2
• Determined as healthy based on screening medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG without clinically significant abnormalities. QTc interval with Fridericia's correction method recorded on screening and predose must be less than 450 msec for male and less than 470 in females.
• Clinical laboratory test result without clinically significant abnormalities at screening and at admission.
• Negative tests for Hepatitis B surface antigen, hepatitis C virus antibodies and human immunodeficiency virus (HIV-1 or HIV-2) antibody at screening.
• Nonsmokers (use of any nicotine containing product) or ex-smokers (have ceased smoking for at least 6 months and do not use any drug for smoking cessation).
• Negative screen for drugs of abuse at screening and admission.
• Negative screen for alcohol at admission.
• For Women: Must have no child-bearing potential by reason of a sterilization procedure or at least 1 year post-menopausal (i.e. 12 months without menstrual period), or menopause confirmed with follicle-stimulating hormone level of \> 30 IU/L at screening.
• For Men: Must be infertile (at least 3-months post-vasectomy), or truly abstinent of heterosexual intercourse, or heterosexual partner is not of child-bearing potential or must agree to use an effective method of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository) through the study and for 28 days after last dose of study drug.
• Able and willing to be available for the duration of the study.
• Willing and able to give written informed consent to participate.
• Able to understand and comply with protocol instructions.
• Agrees not to receive any vaccination within 21 days prior to admission and through Day 7 after final discharge.
• Agrees not to use nonprescription drugs, including vitamins, antacids, and herbal and dietary supplements within 7 days prior to admission and through 7 days after final discharge. Acetaminophen may be used at doses of ≤ 1 g/day, and ibuprofen may be used at doses of ≤ 1.2 g/day.

You may not qualify if:

• Individuals with significant previous or ongoing disease or disorder, based on history, physical exam, ECG, and laboratory tests, including for example: Cardiovascular diseases; hypertension; cancer or neoplasia; diabetes; hepatic, endocrine, metabolic, respiratory, renal, gastrointestinal (except appendectomy), dermatological or hematological disorders, Axis I or II psychiatric, substance use, or cognitive disorders.
• Clinically significant infection or inflammation at time of admission.
• Clinically significant abnormalities upon physical/neurological exam at screening.
• Acute gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea) at admission
• History of treatment from a physician or counselor for abuse or misuse of alcohol, non-prescription drugs, medicinal drugs or other substance abuse.
• Any current or previous use of Class A drugs such as illicit opiate use, cocaine, ecstasy, LSD, and amphetamines (Class B). Volunteers that admit to occasional past use of cannabis will not be excluded as long as they have a negative drugs-of-abuse test at screening and admission and have been abstinent for at least 3 months.
• An alcoholic intake greater than 21 units per week or unwillingness to stop alcohol consumption for the duration of the study. Note: 1 unit = 8 g ethanol (250 mL of beer, 1 glass wine \[100 mL\], 1 measure spirits \[30 mL\]).
• Use of medication (including OTC and oral contraceptive agents) within 14 days of admission that may affect the safety of the subject or any study assessment, in the opinion of the investigator.
• Use of prescribed centrally active or psychoactive agents within 28 days prior to admission.
• Requirement for any medication that would need to be continued during the study.
• Use of any investigational medication within 3 months prior to the start of this study or scheduled to receive an investigational drug during the course of this study.
• Have participated in more than 2 clinical trials involving research medication use within the 12 months prior to screening.
• History of blood donation in the 2 months prior to admission.
• History of severe allergies or multiple adverse drug reactions.
• Any condition, which compromises ability to give informed consent or to communicate with the investigator as required for the completion of this study.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Paul A Newhouse, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Triple-blind safety study. The pharmacist is unblinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: August 9, 2019
• Study Start: May 25, 2021
• Primary Completion: May 25, 2021
• Study Completion: May 25, 2021
• Last Updated: May 28, 2021

Record last verified: 2021-05

Locations

US (1)