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 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT03279302
Eligibility Criteria:
Inclusion Criteria:
* In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations
* Body Mass index between 18 and 30.0 kg/m2
* Able to comply with all the trial procedures
* females will not be pregnant or lactating
* If female of childbearing potential or male agree to use contraception as defined in the protocol
* Male subjects must also be willing to refrain from donating sperm from trial Check-in until 90 days after the last dose
Exclusion Criteria:
* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
* History of bowel obstruction, stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and/or cholecystectomy or hernia repair will be allowed).
* Clinically significant abnormality on 12-lead ECG
* Clinically significant abnormality in hematology, clinical chemistry, or urinalysis
* History of alcoholism or drug/chemical abuse within 2 years
* Alcohol consumption of \> 21 units per week for males and \> 14 units for females
* Positive urine drug screen
* Positive hepatitis panel and/or positive human immunodeficiency test
* Receipt of any investigational product within 30 days or 5 half-lives
* Previous exposure to GLP-1, GLP-2, human growth hormone, or analogs thereof 30 days prior to Check-in
* Use or intend to use any medications/products known to be strong inhibitors or strong inducers of cytochrome P450 3A enzyme, including St. John's wort
* Use of tobacco, smoking cessation products, or products containing nicotine (including but not limited to cigarettes, e-cigarettes, pipes, cigars, chewing tobacco, nicotine lozenges, or nicotine gum ) within 3 months prior to Screening
* Receipt of blood products within 2 months prior to Check-in and throughout the trial.
* Donation of blood or significant blood loss from 56 days prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening and throughout the trial.
* Poor peripheral venous access.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03279302
Study Brief:
Protocol Section:
NCT03279302