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Phase I Study to Evaluate the Safety and Pharmacokinetics of Oral Doses of Anvylic-3288 in Healthy Subjects (AVL3288)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01851603
Recruitment Status : Terminated (PI left institution)
First Posted : May 10, 2013
Last Update Posted : December 30, 2016
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Colorado, Denver

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

Condition or disease Intervention/treatment Phase
Schizophrenia Device: AVL-3288 Drug: Placebo Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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 (Anvylic-3288) Healthy Subjects.
Study Start Date : June 2013
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: AVL-3288
Oral administration of AVL-3288
Device: AVL-3288
Other Name: UCI-4083

Placebo Comparator: Sugar pill
Drug: Placebo
Identical diluent to that used for AVL-3288
Other Name: Diluent solution

Primary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 48 hours ]
    0,1,2,3, 4, 6, 8 ,12, 24, 48 hours post dose

Secondary Outcome Measures :
  1. Number of participants with adverse events. [ Time Frame: 10 days ]
    Corrected QT interval > 500 ms; hepatic enzyme > 3 times above the upper limit of normal values; systolic blood pressure > 200 mm Hg or diastolic blood pressure < 50 mm Hg.

Other Outcome Measures:
  1. Repeatable Battery for Assessment of Neuropsychological Status Total Scale T Score [ Time Frame: 24 hours ]
    T score on Total Scale of the Repeatable Battery for Assessment of Neuropsychological Status, differences between AVL-3288 or placebo arms and pretreatment baseline.

  2. P50 Auditory Sensory Gating Ratio [ Time Frame: 24 hours ]
    Ratio = (Conditioning P50 amplitude-Test P50 Amplitude)/Conditioning P50 Amplitude, differences between AVL-3288 or placebo arms from baseline.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy volunteer

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01851603

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United States, Colorado
U of Colorado Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
National Institute of Mental Health (NIMH)
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Principal Investigator: Robert Freedman, MD U of Colorado Denver

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Responsible Party: University of Colorado, Denver Identifier: NCT01851603     History of Changes
Other Study ID Numbers: 12-1186
1U01MH094247 ( U.S. NIH Grant/Contract )
First Posted: May 10, 2013    Key Record Dates
Last Update Posted: December 30, 2016
Last Verified: December 2016

Keywords provided by University of Colorado, Denver:

Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders