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Phase I Study to Evaluate the Safety and Pharmacokinetics of Oral Doses of Anvylic-3288 in Healthy Subjects

NCT ID: NCT01851603

Last Updated: 2016-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-08-31

Brief Summary

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

Detailed Description

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AVL-3288, a "first in class" small molecule, selective allosteric modulator of the α7 nAChR, is implicated in the cognitive deficit in patients with neurologic and psychiatric disorders, including schizophrenia, Alzheimer's disease and attention deficit hyperactivity disorder. The mechanism of action, the allosteric modulation of α7 nAChR and improvement of cognitive and memory function both in relevant animal models and patients has been clearly described in recent literature. The effect of AVL-3288 strongly supports the rationale for use in schizophrenia given the dose effect relationship, peaking at a low dose in rats (HED 3 mg), in rodent schizophrenia and memory models. Phase I, single-center, inpatient, randomized, double-blind, placebo-controlled, dose escalating study to evaluate the safety, tolerability and pharmacokinetic profiles of single oral doses of AVL-3288 in healthy subjects. Subjects will be hospitalized in the University of Colorado Clinical Research Center (CTSA) for a 12 hour period after the single dose. Then there will be an ambulatory 24 and 48 hour observation and washout period of 10. Patients will receive an evoked potential measurement, the P50 sensory gating paradigm, and the Repeatable Battery for Assessment of Neuropsychological Status.

Conditions

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Schizophrenia

Keywords

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AVL-3288

Oral administration of AVL-3288

Group Type EXPERIMENTAL

AVL-3288

Intervention Type DEVICE

Drug

Sugar pill

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Identical diluent to that used for AVL-3288

Interventions

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AVL-3288

Drug

Intervention Type DEVICE

Placebo

Identical diluent to that used for AVL-3288

Intervention Type DRUG

Other Intervention Names

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UCI-4083 Diluent solution

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteer

Exclusion Criteria

* Substance use. We do not accept inquiries by email.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Freedman, MD

Role: PRINCIPAL_INVESTIGATOR

U of Colorado Denver

Locations

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U of Colorado Denver

Aurora, Colorado, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 17470817 (View on PubMed)

Other Identifiers

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1U01MH094247

Identifier Type: NIH

Identifier Source: secondary_id

View Link

12-1186

Identifier Type: -

Identifier Source: org_study_id