Clinical trial NCT05523596: A Phase 1 Study of the Safety and Tolerability of ICM20 in Adults
Official title: A Phase 1 Non-Randomized Open Label Study of ICM20
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Safety Issues
Lead sponsor: IC-MedTech Corporation
Sponsor class: INDUSTRY
First posted: 2022-08-31
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: through study completion, 90 days
Secondary outcomes:
measure: Percentage of participants on study drug at Day 28 and at Day 60
timeFrame: 60 days
measure: Percentage of participants with a change from baseline in physical examination based on a review of systems
timeFrame: 90 days
measure: 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)
timeFrame: 90 days
measure: Percentage of participants with a change from baseline in blood and urine tests
timeFrame: 90 days
measure: Percentage of participants with a change from baseline in the electrocardiogram
timeFrame: 90 days
Other outcomes:
Locations:
city: Glen Burnie
country: United States
facility: Parkway Medical
state: Maryland
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Falls Church
country: United States
facility: Culmore Clinic
state: Virginia
Study officials:
References: