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 @ 12:38 PM
Ignite Modification Date:
2025-12-24 @ 12:38 PM
NCT ID:
NCT05745961
Eligibility Criteria:
Inclusion Criteria:
Able to provide written informed consent prior to any study mandated procedures.
Able to lie comfortably on back for up to 90 minutes at a time.
Fertile females (women of childbearing potential) are eligible to participate after a negative highly sensitive pregnancy test, if they are taking a highly effective method of contraception other than the oral contraceptive pill until the end of relevant systemic exposure.
Male participants who are fertile are eligible to participate if they are willing to comply with the contraceptive requirements
Exclusion Criteria:
Unable to provide informed consent and/or are non-fluent speakers of the English language
TT Genotype at the rs6971 locus
Clinically-significant renal disease (confirmed by creatinine clearance \<30 ml/min per 1.73m2)
Clinically-significant liver disease (confirmed by serum transaminases \>2 times than upper normal limit)
Anaemia confirmed by haemoglobin concentration \<10 g/dl
Sickle cell disease or thalassaemia
History of uncontrolled systemic hypertension
Acute infection (including eye, dental, and skin infections)
Chronic inflammatory disease including HIV, and Hepatitis B
Women of childbearing potential who are pregnant or breastfeeding
Patients who have received an Investigational Medicinal Product (IMP) within 5 half-lives of the last dose of the IMP or 1 month (which ever is greater) before the baseline visit
Participation in a research study involving significant ionisation radiation within the last 3 years
Significant radiation exposure other than dental X-rays in last 1 year
Positive Allen's test.
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Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
75 Years
Study:
NCT05745961
Study Brief:
Protocol Section:
NCT05745961