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 @ 7:34 PM
Ignite Modification Date:
2025-12-24 @ 7:34 PM
NCT ID:
NCT01332903
Eligibility Criteria:
Inclusion Criteria:
* Have a body mass index (BMI) of ≥18 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-smoker or ex-smoker who has not used tobacco or nicotine products for ≥6 months prior to Visit 1
* Healthy Male volunteers aged 50 and over
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 last 5 years
* History of alcohol abuse or excessive intake of alcohol as judged by the investigator.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
50 Years
Study:
NCT01332903
Study Brief:
Protocol Section:
NCT01332903