Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-24 @ 4:14 PM
NCT ID:
NCT02291666
Eligibility Criteria:
Inclusion Criteria:
* Participants will be ≥18 years old
* Body weight index ≤35,
* Non-smokers (\>3 months)
* Patients with type 2 diabetes and good glycemic control (A1C\<7) or poor glycemic control (A1C\>7.0) and healthy non-diabetic subjects will be eligible.
Exclusion Criteria:
* Subjects with estimated glomerular filtration (MDRD) \<50mL/min/1.73m2
* ALT and AST 3 times above the upper limit of normal
* Organ transplant recipient, inflammatory illnesses (i.e., polyarthritis, severe cirrhosis, infectious diseases, heart failure, HIV, hepatitis)
* Previous history of or an active cancer (except non-melanoma skin cancer)
* Uncontrolled thyroid functions
* Pregnant
* History of drug or alcohol abuse
* Subjects with a history of or current inflammatory bowel diseases including ulcerous colitis and Crohn's disease, and bariatric surgery
* Drugs known to modulate CYP450 activities, subject taking one of the following therapies will be excluded: antibiotics, antivirals, anticancers, CYP450 inducers (carbamazepine, phenobarbital, phenytoin, rifampin, St-John's wort), CYP450 inhibitors (amiodarone, fluvoxamine, fluoxetine, verapamil), immunosuppressors, warfarin, INFs, antibodies or grapefruit juice (\<2-4 weeks) , CYP450 drugs with strong affinity for the selected isoform and with a long half-life, CYP450 mechanism-based inhibitors or an investigational drug
* Intolerance or hypersensitivity to probe drugs in the CRCHUM-MT cocktail or chlorzoxazone/acetaminophen
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02291666
Study Brief:
Protocol Section:
NCT02291666