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 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT03811834
Eligibility Criteria:
Inclusion Criteria:
1. Continuous non smoker who has not used nicotine containing products for at least 20 years prior to the first dosing and throughout the study, based on subject self-reporting.
2. Body mass index greater than or equal to (\>=)18 and less than (˂) 30.0 kilogram per square meter (kg/m\^2) at screening.
Exclusion Criteria:
1. Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
2. Has history or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
3. Has positive urine drug or alcohol results at screening or first check in.
4. Estimated creatinine clearance \< 80 milliliter per minute (mL/min) at screening.
5. Has tattoo(s) or scarring at or near the site of intravenous (IV) infusion or any other condition which may interfere with infusion site examination, in the opinion of the investigator.
6. Has infrequent bowel movements (less than approximately once per day) within 30 days prior to first dosing.
7. Has recent history of abnormal bowel movements, such as diarrhea, loose stools, or constipation, within 2 weeks of first dosing.
8. Has received radiolabeled substances or has been exposed to radiation sources within 12 months of first dosing or is likely to receive radiation exposure or radioisotopes within 12 months of first dosing such that participation in this study would increase their total exposure beyond the recommended levels considered safe (that is., weighted annual limit recommended by the Commission on Radiological Protection \[ICRP\] of 3000 millirem).
9. Donation of blood or significant blood loss within 56 days prior to the first dosing.
10. Plasma donation within 7 days prior to the first dosing.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
19 Years
Maximum Age:
55 Years
Study:
NCT03811834
Study Brief:
Protocol Section:
NCT03811834