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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT04952467
Eligibility Criteria:
Key Inclusion Criteria:
* Body mass index (BMI) of 18.0 to 32.0 kg/m2
* Must be willing and able to communicate and participate in the whole study
* Provide written informed consent
* Adhere to the specified contraception requirements
Key Exclusion Criteria:
* Subjects who have received any investigational medicinal product (IMP) in a clinical research study within 90 days
* Evidence of any current infection or an infection within 14 days before study drug administration
* History of any drug or alcohol abuse in the past 2 years
* Subjects with pregnant or lactating partners
* Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 millisievert (mSv) in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study
* Participation in a clinical trial involving administration of radiolabelled compound(s) within 180 days of the planned dosing date of this study
* Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis. Subjects with Gilbert's Syndrome will be excluded.
* Confirmed positive drugs of abuse test result
* Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results
* History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder
* Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
30 Years
Maximum Age:
65 Years
Study:
NCT04952467
Study Brief:
Protocol Section:
NCT04952467