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:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT04819620
Eligibility Criteria:
Key Inclusion Criteria:
* Subjects must have BMI between 18 and 32 kg/m2
* Subjects must be non-smokers or social smokers
* Subjects must comply with contraception requirements
* Subjects must be willing to consume meals provided by the clinical center
* Subjects must be willing to attend required clinic visits
* Subjects must be suitable candidates for study procedures
Key Exclusion Criteria:
* Subject with a history of clinically significant endocrine, neurological, cardiovascular, hematological, hepatic, immunological, renal, respiratory, gastrointestinal or genitourinary abnormalities or diseases within previous 10 years
* Subjects with a history of surgical resection of the stomach, small or large intestine
* Subjects with a fever or symptomatic viral or bacterial infection within 2 weeks of screening or intestinal infection within 30 days prior to screening
* Subjects with clinically significant laboratory abnormalities
* Subjects with corrected QT greater than 450 msec in males and 470 msec in females
* Subjects who test positive for Hepatitis C or B, or HIV at Screening
* Subjects who cannot refrain from use of prescription and non-prescription drugs and herbal remedies prior to initial dose of study drug and throughout the study
* Subjects who test positive for drugs of abuse or alcohol at Screening
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04819620
Study Brief:
Protocol Section:
NCT04819620