A Phase 1 Non-Randomized Open Label Study of ICM20

ICM003

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

2022-12-20

2026-12-01

2027-03-01

Recruiting

Early phase I

24

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 24, 'type': 'ESTIMATED'}}

2023-10-16