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 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT04390334
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
* Healthy male subjects aged between 18 and 45 years (inclusive) at Screening.
Exclusion Criteria:
* Clinically relevant findings on the physical examination at Screening.
* Clinically relevant abnormalities on 12-lead ECG, measured after at least 5 min in a supine position at Screening.
* Clinically relevant findings in clinical laboratory tests (hematology, clinical chemistry) at Screening and on Day -1.
* History of major medical or surgical disorders which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment(s) (appendectomy and herniotomy allowed, cholecystectomy not allowed).
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
* Moderate or severe renal insufficiency (creatinine clearance \< 60 mL/min calculated with the Cockcroft Gault formula) at Screening.
* Total bilirubin \> 1.5 x Upper Limit of Normal at Screening.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT04390334
Study Brief:
Protocol Section:
NCT04390334