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 @ 3:56 PM
Ignite Modification Date:
2025-12-24 @ 3:56 PM
NCT ID:
NCT05201092
Eligibility Criteria:
Inclusion Criteria:
* The participant has a body mass index (BMI) ≥18.5 and ≤30 kilograms (kg)/square meter (m\^2) and a body weight of ≥60 kg at the Screening Visit and at the Baseline Visit.
* The participant has a resting supine systolic blood pressure ≥91 and ≤140 millimeters of mercury (mmHg) and a resting supine diastolic blood pressure ≥51 and ≤85 mmHg at the Screening Visit and at the Baseline Visit.
* The participant is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, neurological examination, vital signs, an electrocardiogram (ECG), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.
Exclusion Criteria:
* The participant has taken disallowed medication \<1 week prior to the first dose of study drug or \<5 half-lives prior to the Screening Visit for any medication taken.
* The participant has orthostatic hypotension, defined as a decrease in systolic blood pressure ≥20 mmHg or a decrease in diastolic blood pressure ≥10 mmHg from supine to standing, at the Screening Visit or at the Baseline Visit.
* The participant has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.
* The participant has received a COVID-19 vaccination less than 30 days prior to the first dose of study drug.
* The participant trains/exercises intensively, for example, for a marathon or triathlon, or at a competitive level.
* The participant is exposed to significant levels of ionizing radiation at work.
* The participant has undergone any clinical procedures involving significant exposure to radiation (excluding dental X-ray and common X-rays of the chest or extremities) \<12 months prior to the Screening Visit.
* The participant has received radiolabelled material \<12 months prior to the Screening Visit.
Note: Other inclusion and exclusion criteria may apply.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
45 Years
Maximum Age:
60 Years
Study:
NCT05201092
Study Brief:
Protocol Section:
NCT05201092