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 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
NCT ID:
NCT05671666
Eligibility Criteria:
Inclusion Criteria:
* healthy subjects at any age and given written informed consent
* subjects with a UCD confirmed by genetic or enzymatic diagnostics at any age and given written informed consent
Exclusion Criteria:
* healthy subjects with acute and chronic disease requiring treatment of any kind
* pregnant or lactating women.
* UCD patients with acute and chronic (other than her/his UCD) disease requiring treatment
* UCD patients in which intake of carglumic acid cannot be stopped for 24 hours prior to the test
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT05671666
Study Brief:
Protocol Section:
NCT05671666