Overview
The purpose of this study is to evaluate the safety, tolerability, and efficacy of MZE782 in adults with Phenylketonuria (PKU).
Eligibility
Key Inclusion Criteria:
- Males and females 18 to 75 years old
- Clinical diagnosis of PKU
- Willing and able to keep diet and protein intake consistent during the study
- For some study groups, is willing and able to stop certain PKU medications before starting study treatment
- For some study groups, may need to meet additional blood phenylalanine level or background-treatment requirements
- Meets minimum blood phenylalanine level requirements for study group
Key Exclusion Criteria:
- Is pregnant, breastfeeding, or planning to become pregnant or conceive a child during the study or within 90 days after the last dose
- Medical conditions or abnormal test results that could make participation unsafe or make it difficult to complete study procedures or interpret study results
- Has recently received another investigational drug
- Is unable to swallow tablets or tolerate oral medication
Other inclusion/exclusion criteria defined in protocol apply.
