NCT01851603

Brief Summary

This is a brief inpatient study to determine the safety of a new drug in healthy people.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 schizophrenia

Timeline
Completed

Started Jun 2013

Longer than P75 for phase_1 schizophrenia

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 10, 2013

Completed
22 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

December 30, 2016

Status Verified

December 1, 2016

Enrollment Period

3.2 years

First QC Date

May 6, 2013

Last Update Submit

December 28, 2016

Conditions

Schizophrenia

Keywords

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Maximum Observed Plasma Concentration (Cmax)

    0,1,2,3, 4, 6, 8 ,12, 24, 48 hours post dose

    48 hours

Secondary Outcomes (1)

  • Number of participants with adverse events.

    10 days

Other Outcomes (2)

  • Repeatable Battery for Assessment of Neuropsychological Status Total Scale T Score

    24 hours

  • P50 Auditory Sensory Gating Ratio

    24 hours

Study Arms (2)

AVL-3288

EXPERIMENTAL

Oral administration of AVL-3288

Device: AVL-3288

Sugar pill

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

AVL-3288DEVICE

Drug

Also known as: UCI-4083
AVL-3288
PlaceboDRUG

Identical diluent to that used for AVL-3288

Also known as: Diluent solution
Sugar pill

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteer

You may not qualify if:

  • Substance use. We do not accept inquiries by email.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

  • Ng HJ, Whittemore ER, Tran MB, Hogenkamp DJ, Broide RS, Johnstone TB, Zheng L, Stevens KE, Gee KW. Nootropic alpha7 nicotinic receptor allosteric modulator derived from GABAA receptor modulators. Proc Natl Acad Sci U S A. 2007 May 8;104(19):8059-64. doi: 10.1073/pnas.0701321104. Epub 2007 Apr 30.

    PMID: 17470817BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Robert Freedman, MD

    U of Colorado Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2013

First Posted

May 10, 2013

Study Start

June 1, 2013

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

December 30, 2016

Record last verified: 2016-12

Locations

US(1)