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

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.

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01851603

Acronym

AVL3288

Enrollment

Registered

2013-05-10

Start date

2013-06-30

Completion date

2016-08-31

Last updated

2016-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Schizophrenia

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.

Interventions

DEVICEAVL-3288

Drug

DRUGPlacebo

Identical diluent to that used for AVL-3288

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy volunteer

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Other

Measure	Time frame	Description
Repeatable Battery for Assessment of Neuropsychological Status Total Scale T Score	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.
P50 Auditory Sensory Gating Ratio	24 hours	Ratio = (Conditioning P50 amplitude-Test P50 Amplitude)/Conditioning P50 Amplitude, differences between AVL-3288 or placebo arms from baseline.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026