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

Completed · Phase 1

Conditions studied: Safety Issues

In brief

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

Key facts

Study ID

NCT05523596

Run by

IC-MedTech Corporation

People needed

13

Starts

2023-08-20

Expected to finish

2025-10-03

Last updated by the study team

2026-04-16

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥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

Where it is running

• Parkway Medical — Glen Burnie, Maryland, United States
• Baylor College of Medicine — Houston, Texas, United States
• Culmore Clinic — Falls Church, Virginia, United States

Full record on ClinicalTrials.gov

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