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 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT05564104
Eligibility Criteria:
Inclusion Criteria:
* Male or female.
* Part A: Aged 18-80 years (both inclusive) at the time of signing informed consent.
* Part B: Aged 18-60 years (both inclusive) at the time of signing informed consent.
* Part A: Body mass index (BMI) between 18.5-39.9 kilograms per meter square (kg/m\^2) (both inclusive).
* Part B: BMI between 25-30 kg/m2 (both inclusive).
* Specific inclusion criterion only for Part A participants with hepatic impairment: Participants with stable hepatic impairment classified as Child-Pugh grade A, B or C as assessed by the investigator. Stable hepatic impairment is defined as no clinically significant change in disease status, as judged by the investigator.
Exclusion Criteria:
* Known or suspected hypersensitivity to study intervention(s) or related products.
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05564104
Study Brief:
Protocol Section:
NCT05564104