Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
IC-MedTech Corporation
This is a Phase 1 open label study to access the safety and tolerability of ICM20 alone and in combination with benznidazole
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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
You may not be if
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
