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 @ 3:03 PM
Ignite Modification Date:
2025-12-24 @ 3:03 PM
NCT ID:
NCT04940559
Eligibility Criteria:
Key Inclusion Criteria:
* Healthy was defined as having no clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and heart rate measurements, 12-lead electrocardiogram, and clinical laboratory tests.
* Had a body mass index of 18 to 30 kilograms(kg)/meter squared with a minimum body weight of 50 kg.
Key Exclusion Criteria:
* History or clinically relevant evidence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
* History of procedures that could alter absorption of orally administered drugs.
* Body temperature ≥ 38°Celsius on Day -1 or Day 1 predose; history of febrile illness within 7 days prior to study drug administration.
* Positive alcohol and/or drug screen at Screening or Day -1; current tobacco/nicotine user.
* Participation in a clinical study within 30 days prior to study drug administration.
* Clinically significant laboratory abnormalities at Screening or Day -1.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT04940559
Study Brief:
Protocol Section:
NCT04940559