A Phase 1 Study to Evaluate Effects of Sapropterin Dihydrochloride on QTc Intervals in Healthy Adult Subjects
Status:
Completed
Trial end date:
2009-10-01
Target enrollment:
Participant gender:
Summary
Sapropterin dihydrochloride (subsequently referred to as sapropterin) (Kuvan®) was approved
by the FDA for the treatment of hyperphenylalaninemia in 2007. Preclinical and clinical
studies and post-marketing surveillance have not demonstrated any specific cardiovascular
concerns with sapropterin (Kuvan®). Nonetheless, nonantiarrhythmic drugs may have the
potential to prolong QT interval, leading to potentially fatal ventricular tachycardias,
including torsades de pointes. As part of the post-marketing commitment, a thorough QT/QTc
study will be conducted according to ICH guidelines.
Phase:
Phase 1
Details
Lead Sponsor:
BioMarin Pharmaceutical
Treatments:
Fluoroquinolones Moxifloxacin Norgestimate, ethinyl estradiol drug combination Verapamil