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 @ 1:29 PM
Ignite Modification Date:
2025-12-24 @ 1:29 PM
NCT ID:
NCT06857695
Eligibility Criteria:
Inclusion Criteria:
* Healthy males aged 30 to 65 years inclusive
* BMI in the range 18.0 - 35.0 kg/m2 and body weight ≥63 kg
* Regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day)
Exclusion Criteria:
* History of any clinically significant disease or disorder
* History or presence of clinically significant gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity
* Excessive intake of caffeine containing drinks or food
* History/family history of medullary thyroid carcinoma or multiple endocrine neoplasia
* Uncontrolled thyroid disease
* History of acute pancreatitis or gallstones
* Serum triglyceride concentrations \> 1000 mg/dL (11 mmol/L)
* Any history of significant inflammatory bowel disease, gastroparesis, or other severe disease or prior surgery affecting the upper GI tract
* Participants who do not have suitable veins for multiple venepunctures/cannulation
* Clinically significant abnormal clinical chemistry, haematology or urinalysis
* Significant hepatic disease
* Any clinically significant abnormalities in rhythm, conduction, or morphology of the resting ECG and any clinically important abnormalities in the 12-lead ECG
* Abnormal renal function
* Radiation exposure exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years, occupationally exposed worker, or have been administered IMP in a \[14C\] ADME study in the last 12 months.
* Use of any prescribed or non-prescribed medication
* Current smokers or known or suspected history of alcohol or drug abuse.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
30 Years
Maximum Age:
65 Years
Study:
NCT06857695
Study Brief:
Protocol Section:
NCT06857695