Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
BioMarin Pharmaceutical
Age
8–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
8 years of age and older
Prior successful participation in Study PKU-003
Willing and able to provide written informed consent or assent and written informed consent (if required) by a parent or legal guardian
For females of child-bearing potential only: Negative urine pregnancy test within 24 hours prior to enrollment. Women using acceptable birth control measures must agree to continue to use those measures while participating in the study
Willing and able to comply with study procedures
Willing to continue current diet unchanged while participating in the study
You may not be if
Perceived to be unreliable or unavailable for study participation or, if under the age of 18, have parents or legal guardians who are perceived to be unreliable or unavailable
Withdrew from, or otherwise did not successfully complete, study PKU-003, except for subjects who were removed from the study because their blood Phe exceeded the alert level
Expected to require any investigational agent or vaccine prior to completion of all scheduled study assessments
Pregnant or breastfeeding, or planning pregnancy
Concurrent disease or condition that would interfere with study participation or safety (e.g., seizure disorder, oral steroid-dependent asthma or other condition requiring oral or parenteral corticosteroid administration, or insulin-dependent diabetes)
Requirement for concomitant treatment with any drug known to inhibit folate synthesis (e.g., methotrexate)
