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 @ 10:09 PM
Ignite Modification Date:
2025-12-24 @ 10:09 PM
NCT ID:
NCT02434835
Eligibility Criteria:
Inclusion Criteria:
* Subjects who are male, caucasian, and between 35 and 55 years of age, inclusive.
* Subjects who have a body mass index (BMI) between 18.5 and 30.0 kg/m2, inclusive.
* Subjects who have a body weight between 50 and 100 kg, inclusive.
* Subjects must have regular bowel movements.
Exclusion Criteria:
* Subjects who have an abnormality in heart rate, blood pressure , temperature or 12-lead ECG.
* Subjects who are still participating in a clinical study or who have participated in a clinical study involving administration of an investigational drug in the 3 months prior to dose administration.
* Subjects who have had a clinically significant illness within 4 weeks of dose administration as determined by the Investigator.
* Subjects who have any clinically significant abnormal laboratory safety findings.
* Subjects who have had an X ray or who have participated in any clinical trial involving a radiolabelled investigational product or have been exposed to radiolabelled substances within 12 months prior to dose administration.
Sex:
MALE
Minimum Age:
35 Years
Maximum Age:
55 Years
Study:
NCT02434835
Study Brief:
Protocol Section:
NCT02434835