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 @ 2:09 PM
Ignite Modification Date:
2025-12-24 @ 2:09 PM
NCT ID:
NCT01284595
Eligibility Criteria:
Inclusion Criteria:
* Have a body mass index (BMI) of ≥19 and ≤30 kg/m2 and weight of ≥50 kg and ≤100 kg.
* Regular daily bowel movements (ie, production of at least 1 stool per day).
* Non-smokers or ex-smokers who have stopped smoking for \>3 months before Visit 1 and have not used nicotine products for \>3 months
* Healthy Male volunteers aged 50 to 65 years, inclusive
Exclusion Criteria:
* Healthy volunteers who have been exposed to radiation levels above background (eg, through X-ray examination) of \>5 mSv in the last year, \>10 mSv in the last 5 years, or a cumulative total of \>1 mSv per year of life
* Participation in any prior radiolabelled study within 12 months of the screening visit (Visit 1).
* History of alcohol abuse or excessive intake of alcohol defined as regular weekly intake of 28 units of alcohol or more (1 unit=25 mL spirits, 125 mL wine, 250 mL beer or lager)
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
50 Years
Maximum Age:
65 Years
Study:
NCT01284595
Study Brief:
Protocol Section:
NCT01284595