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

University of Colorado Denver (CU Denver)

Status and phase: Terminated; Phase 1

Conditions: Schizophrenia

Treatments: Device: AVL-3288; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01851603

1U01MH094247 (U.S. NIH Grant/Contract)

12-1186

Details and patient eligibility

About

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

Full 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.

Enrollment: 12 patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteer

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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12 participants in 2 patient groups, including a placebo group

AVL-3288

Experimental group

Description:

Oral administration of AVL-3288

Treatment:

Device: AVL-3288

Sugar pill

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo