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 @ 1:43 AM
Ignite Modification Date:
2025-12-25 @ 1:43 AM
NCT ID:
NCT01395394
Eligibility Criteria:
Inclusion Criteria:
* Have read, understood, and signed this consent form (and assent form, if \<18 years old)
* Are between the ages of 10-45 years
* Weigh at least 75 pounds (34 kg)
* Meet group-specific criteria
Exclusion Criteria:
* Smoke
* Have any history of cardiovascular disease
* Have hepatic impairment, or demonstrate abnormal baseline liver function lab test results
* Have donated blood within 3 months prior to the study or are anemic as shown by the baseline lab results
* Are unwilling to discontinue dietary supplements (excluding medical food) two weeks prior to their first study visit
* Are currently take medications that will interfere with the interpretation of selected endpoints (such as lipid-lowering medication)
* Are currently pregnant or breastfeeding
* Excluding PKU, have a chronic illness, disorder, or condition (including but not limited to diabetes, hypertension, cancer)
* Have taken any investigational drug (including Kuvan for Kuvan-unresponsive participants \& controls) within 3 months prior to the study
* In the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
45 Years
Study:
NCT01395394
Study Brief:
Protocol Section:
NCT01395394