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 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT02072993
Eligibility Criteria:
Inclusion Criteria:
* Provision of signed and dated, written informed consent prior to any study specific procedures
* Healthy male volunteer aged 18 to 50 years
* Have a BMI between 18 and 30 kg/m2, inclusive, and weigh at least 50 kg and no more than 100 kg, inclusive
Exclusion Criteria:
* History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study
* History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
* Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IP
* Any clinically important abnormalities in clinical chemistry, endocrine hormones, hematology, or urinalysis results as judged by the Investigator
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02072993
Study Brief:
Protocol Section:
NCT02072993