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

Phase 1

Terminated

• Conditions: Schizophrenia
• Interventions: Device: AVL-3288; Drug: Placebo

• Registration Number: NCT01851603
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2013-05-06
• Study First Submitted QC: 2013-05-09
• Study First Posted: 2013-05-10
• Study Start: 2013-06
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-28
• Last Update Posted: 2016-12-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

• Healthy volunteer

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AVL-3288	AVL-3288	Oral administration of AVL-3288
Sugar pill	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Maximum Observed Plasma Concentration (Cmax)	48 hours	0,1,2,3, 4, 6, 8 ,12, 24, 48 hours post dose

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events.	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.

Trial Locations

Locations (1)

U of Colorado Denver; 🇺🇸 Aurora, Colorado, United States