A Phase 1 Study of the Safety and Tolerability of ICM20 in Adults

Study Overview
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Brief Summary
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A Phase 1 Non-Randomized Open Label Study of Oral ICM20

Detailed Description
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This is a Phase 1 open label study to access the safety and tolerability of ICM20 alone and in combination with benznidazole

Official Title
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A Phase 1 Non-Randomized Open Label Study of ICM20

Conditions
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Safety Issues

Intervention / Treatment
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* Drug: ICM20
* Drug: Benznidazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 to 70 years of age ≥125 and ≤200 pounds Diagnosis of chagas documented by positive serology No prior chagas treatment Able to swallow capsules and tablets Laboratory values: Blood: Hemoglobin ≥9; Polymorphonuclear white blood cells >1000; Platelets >50,000 Liver Function Tests ≤ 2 Times Upper Limit of Normal Serum Creatinine ≤2.0 Prothrombin time, partial thromboplastin time within normal limits HemoglobinA1C <7 Human immunodeficiency virus negative Stable on current prescription medications Not pregnant, lactating, or planning to get pregnant Both men and women who are not surgically sterile, or post-menopausal, must agree to avoid pregnancy Willing to abstain from alcohol Able and willing to give informed consent Exclusion Criteria:• Prior chagas treatment Known hypersensitivity to either study drug or its constituents Requires the continuing use of amiodarone, monoamine oxidase inhibitors, phenytoin, phenobarbital, disulfiram, anticoagulants or procoagulants, drugs or products containing alcohol or propylene glycol. Coagulopathy Glucose-6-phosphate dehydrogenase deficiency History, signs, or symptoms of heart failure History of heartburn, gastroesophageal reflux disease, or ulcers Unstable medical condition Immunodeficiency Requires surgery or surgical procedure within 90 days of Screening. Use of an investigational product within 56 days prior to baseline Unwilling to discontinue use of disallowed products Unable to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Other
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose Level 1<br>ICM20 | Drug: ICM20<br>* small molecules<br>|
| Experimental: Dose Level 2<br>ICM20 and benznidazole ascending dose 2 | Drug: ICM20<br>* small molecules<br>Drug: Benznidazole<br>* small molecule<br>|
| Experimental: Dose Level 3<br>ICM20 and benznidazole ascending dose 3 | Drug: ICM20<br>* small molecules<br>Drug: Benznidazole<br>* small molecule<br>|
| Experimental: Dose Level 4<br>ICM20 and benznidazole ascending dose 4 | Drug: ICM20<br>* small molecules<br>Drug: Benznidazole<br>* small molecule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events | Number of participants with treatment related adverse events, based on a modified World Health Organization toxicity grading scale | through study completion, 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants on study drug at Day 28 and at Day 60 | Percentage of participants that are still taking the assigned study drug at Day 48 and at Day 60 | 60 days | 
| Percentage of participants with a change from baseline in physical examination based on a review of systems | Percentage of participants that demonstrate a clinically relevant change from baseline on physical examination based on a review of systems | 90 days | 
| Percentage of participants with a change from baseline in vital signs (temperature in degrees Fahrenheit, respiratory rate in breaths per minute, heart rate in beats per minute, blood pressure in millimeters mercury) | Percentage of participants with a clinically relevant change from baseline in vital signs | 90 days | 
| Percentage of participants with a change from baseline in blood and urine tests | Percentage of participants that show a clinically relevant change from baseline | 90 days | 
| Percentage of participants with a change from baseline in the electrocardiogram | Percentage of participants that show a change in the twelve lead electrocardiogram | 90 days |