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 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT04923269
Eligibility Criteria:
Inclusion Criteria:
* Overtly healthy males or females not of childbearing potential.
* Body mass index (BMI) within the range of 18.5 to 40 kilograms per meter squared (kg/m²), inclusive
Exclusion Criteria:
* Have a significant history of or current CV (e.g., myocardial infarction, congestive heart failure, cerebrovascular accident, venous thromboembolism), respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk while taking the study intervention; or of interfering with the interpretation of data
* Have a history of malignancy within 5 years prior to screening
* Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis
* Have serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2X the upper limit of normal (ULN) or total bilirubin level (TBL) \>1.5X ULN
* Have serum triglyceride level ≥5 mmol/L (442.5 mg/dL)
* Have undergone any form of bariatric surgery
* Have received systemic or inhaled glucocorticoid therapy (excluding topical, intraarticular, and intraocular preparations); for more than 14 consecutive days within 4 weeks before screening
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
70 Years
Study:
NCT04923269
Study Brief:
Protocol Section:
NCT04923269