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 @ 7:52 PM
Ignite Modification Date:
2025-12-24 @ 7:52 PM
NCT ID:
NCT03787004
Eligibility Criteria:
Key Inclusion Criteria:
* Is in good general health as determined by the Investigator's review
* Has a body mass index (BMI) between 18 and 35kg/m\^2, inclusive
* For females, is not currently pregnant or breastfeeding and is either of non-childbearing potential or willing to use an adequate method of birth control
* For males, must agree to use barrier contraception and not to donate sperm
Key Exclusion Criteria:
* Has a history of cardiac disease, including congestive heart failure, angina, or any arrhythmia
* Has diabetes mellitus, acromegaly, clinically active thyroid disease, or other active endocrinopathy
* Has any history or currently active type of cancer except excised or cured basal cell carcinoma
* Has a gastrointestinal disorder that could interfere with the absorption of orally administered drugs
* Has asthma or other severe respiratory disease (e.g., chronic obstructive pulmonary disease) requiring daily prescription medicine
* Currently has kidney, neurologic, metabolic, or liver disease, or other organ system disease
* Has a history, current evidence, or is being treated for depression, suicidal ideation, suicide attempt, or any other current psychiatric condition requiring active treatment
* Has an immunological disorder such as, but not limited to, human immunodeficiency virus (HIV), acquired, or congenital immune deficiency syndrome; autoimmune diseases, such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, seronegative spondyloarthropathies or vasculitis, or any infection
* Has positive screening test for hepatitis B virus (HBV) or hepatitis C virus (HCV);
* Is pregnant, lactating, or planning a pregnancy during the study
* Has used any prescribed medication within 30 days prior to the first admission or has plans to use any prescribed medication during the study (with the exception of hormonal contraceptives)
* Has used within 14 days prior to the first admission or has plans to use during the study any over-the-counter medicinal products, including herbal and dietary supplements (except for occasional use of acetaminophen or NSAIDs, such as ibuprofen or naproxen; calcium; or Vitamin D)
* Use of any of the following:
* Human growth hormone, octreotide, anti-diabetic medication, or thyroid suppressors or supplements
* Immunosuppressive drugs within 30 days of study start, or 5 half-lives of the drug (whichever is longer), or plans to use during the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT03787004
Study Brief:
Protocol Section:
NCT03787004