Study Effect of VIA-2291 on Vascular Inflammation

Study Overview
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Brief Summary
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This is a dose ranging study to compare the effect of VIA-2291 vs. Placebo on various inflammatory biomarkers in patients with recent acute coronary events

Detailed Description
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This is a Phase II, randomized, double-blind, placebo-controlled study of the effect of VIA-2291 on atherosclerotic vascular inflammation

Official Title
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Clinical Study Protocol No. VIA-2291-01, A Phase 2 Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose-ranging Study of the Effect of VIA-2291 on Vascular Inflammation in Patients After an Acute Coronary Syndrome Event

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: VIA-2291
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients are to be of non-childbearing potential Patient has suffered an ST elevation myocardial infarction (MI), non-ST elevation MI, or unstable angina 21 days (±3 days) prior to study randomization Patient has documented coronary artery disease Exclusion Criteria: Renal insufficiency defined as creatinine >1.5 x upper limit of normal (ULN) Cirrhosis, recent hepatitis, ALT >1.5 x ULN or ALT > 1 x ULN and at least one other liver function test Uncontrolled diabetes mellitus within 1 month prior to study screening Congestive heart failure (CHF) defined by the New York Heart Association as functional Class III or IV Previous coronary artery bypass graft (CABG) surgery Planned additional cardiac intervention Recurrence of ST elevation MI, non-ST elevation MI, or unstable angina less than 18 days prior to randomization Current atrial fibrillation, atrial flutter, or frequent premature ventricular contractions Acetaminophen use in any form in the 7 days before enrollment

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VIA-2291 25 mg<br>VIA-2291 25 mg | Drug: VIA-2291<br>* oral dosing, 1 time daily for 12 or 24 weeks<br>* Other names: atreleuton;|
| Experimental: VIA-2291 50 mg<br>VIA-2291 50 mg | Drug: VIA-2291<br>* oral dosing, 1 time daily for 12 or 24 weeks<br>* Other names: atreleuton;|
| Experimental: VIA-2291 100 mg<br>VIA-2291 100 mg | Drug: VIA-2291<br>* oral dosing, 1 time daily for 12 or 24 weeks<br>* Other names: atreleuton;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* oral dosing, 1 time daily for 12 or 24 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline on ex Vivo Leukotriene B4 Synthesis in Whole Blood |  | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Leukotriene E4 (LTE4) | Urinary LTE4 is expressed in pg per mg Creatinine (pg/mg Cr) to normalize for renal excretion rate | Baseline and 12 weeks | 
| Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - Core Study |  | Baseline and 12 weeks |