Safety Issues
Conditions
Brief summary
A Phase 1 Non-Randomized Open Label Study of Oral ICM20
Detailed description
This is a Phase 1 open label study to access the safety and tolerability of ICM20 alone and in combination with benznidazole
Interventions
DRUGICM20
small molecules
DRUGBenznidazole
small molecule
Sponsors
IC-MedTech Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | through study completion, 90 days | Number of participants with treatment related adverse events, based on a modified World Health Organization toxicity grading scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants on study drug at Day 28 and at Day 60 | 60 days | Percentage of participants that are still taking the assigned study drug at Day 48 and at Day 60 |
| Percentage of participants with a change from baseline in physical examination based on a review of systems | 90 days | Percentage of participants that demonstrate a clinically relevant change from baseline on physical examination based on a review of systems |
| 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) | 90 days | Percentage of participants with a clinically relevant change from baseline in vital signs |
| Percentage of participants with a change from baseline in blood and urine tests | 90 days | Percentage of participants that show a clinically relevant change from baseline |
| Percentage of participants with a change from baseline in the electrocardiogram | 90 days | Percentage of participants that show a change in the twelve lead electrocardiogram |
Countries
United States
Outcome results
None listed