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 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT02126956
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent prior to any study-mandated procedure.
* Male and aged between 45 and 65 years (inclusive) at screening.
* No clinically significant findings on physical examination performed at screening.
* Body mass index (BMI) between 18-28 kg/m\^2 (inclusive) at screening.
* Systolic blood pressure 100-145 mmHg, diastolic blood pressure 50-90 mmHg, and heart rate 55-90 bpm (inclusive), measured on the leading arm, after 5 minutes in the supine position at screening. These criteria should also be met before the administration of the first dose.
* 12-lead electrocardiogram without clinically relevant abnormalities at screening.
* Clinical chemistry, hematology, and urinalysis results not deviating from the normal range to a clinically relevant extent at screening.
* Negative results from urine drug screen at screening.
* Ability to communicate well with the investigator in the local language, and to understand and comply with the requirements of the study.
Exclusion Criteria:
* Known hypersensitivity to any excipients of the drug formulation.
* Treatment with another investigational drug within the 3 months prior to screening.
* History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening.
* Excessive caffeine consumption, defined as ≥ 800 mg per day at screening.
* History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drug.
* Smoking within the 3 months prior to screening.
* Any immunosuppressive treatment within 6 weeks before study drug administration.
* Previous treatment with any prescribed or over-the-counter medications (including herbal medicines such as St John's Wort) within 2 weeks prior to screening.
* Loss of 250 mL or more of blood within the 3 months prior to screening.
* Lymphopenia (\< 1,100 lymphocytes/μL).
* Viral, fungal, bacterial or protozoal infection within 4 weeks before study drug administration.
* Positive hepatitis B or hepatitis C serology, except for vaccinated subjects, at screening.
* Positive human immunodeficiency virus serology at screening.
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
* Legal incapacity or limited legal capacity at screening.
* Exposure to artificial ionizing radiation (e.g., X-ray, thyroid scan, study with radiolabeled compound) in the 12-month period before screening.
* A history of clinically relevant constipation (defined as lasting more than 3 days) in the 4-week period before screening.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
45 Years
Maximum Age:
65 Years
Study:
NCT02126956
Study Brief:
Protocol Section:
NCT02126956