Clinical Trials Logo
  1. Home
  2. Phenylketonuria
  3. NCT00789568

A Phase 1 Study to Evaluate Effects of Sapropterin Dihydrochloride on QTc Intervals in Healthy Adult Subjects

Phenylketonuria Clinical Trial

Official title:
A Phase 1, Randomized, Placebo- and Active-controlled Crossover Study to Evaluate the Effects of Sapropterin Dihydrochloride Oral Administration on QTc Intervals in Healthy Adult Subjects

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00789568
Study type Interventional
Source BioMarin Pharmaceutical
Contact
Status Completed
Phase Phase 1
Start date October 2008
Completion date October 2009
View Details
See also
  Status Clinical Trial Phase
Completed NCT05099640 - A Study of PTC923 in Participants With Phenylketonuria Phase 3
Completed NCT01924026 - Neurocognitive Outcomes in Mild Hyperphenylalaninemia (MHP)MHP Study N/A
Completed NCT01428258 - Phase 2 Study of Glycomacropeptide Versus Amino Acid Diet for Management of Phenylketonuria N/A
Completed NCT00925054 - Dose-Finding Study to Evaluate the Safety, Efficacy, & Tolerability of Multiple Doses of rAvPAL-PEG in Subjects With PKU Phase 2
Completed NCT00778206 - PKUDOS: Phenylketonuria (PKU) Demographic, Outcomes, and Safety Registry
Recruiting NCT05948020 - Efficacy and Safety of Orally Administered Engineered Probiotics (CBT102-A) for the Treatment of Children With Phenylketonuria N/A
Recruiting NCT05781399 - First-in-Human, Multiple Part Clinical Study of JNT-517 in Healthy Participants and in Participants With Phenylketonuria Phase 1
Completed NCT02555579 - Simplified Diet Approach in Phenylketonuria N/A
Completed NCT03097250 - MRI Spectroscopy and Neuropsychological Functioning in Phenylketonuria
Completed NCT01965912 - Kuvan®'s Effect on the Cognition of Children With Phenylketonuria Phase 4
Completed NCT01965691 - Protein Requirements in Children With Phenylketonuria (PKU) N/A
Completed NCT00688844 - Nutritional and Neurotransmitter Changes in PKU Subjects on BH4 N/A
Terminated NCT01465100 - Liver Cell Transplant for Phenylketonuria Phase 1/Phase 2
Completed NCT01732471 - Phase 3 Open-label Study to Evaluate the Response and Safety of Kuvan® in Subjects With Phenylketonuria Phase 3
Completed NCT04879277 - Study of Low-grade Systemic Inflammation in Adult Patients With Phenylketonuria N/A
Completed NCT02176603 - Observational Study of Endothelial Dysfunction in Phenylketonuria N/A
Completed NCT01819727 - An Open-Label Phase 3 Study of BMN 165 for Adults With PKU Not Previously Treated w/ BMN 165 Phase 3
Completed NCT01869972 - Biological Variation of Phenylalanine in Patients With Hyperphenylalaninemia N/A
Terminated NCT01904708 - Moderate Intensity Exercise and Phenylketonuria N/A
Completed NCT01560286 - A Study to Evaluate Subcutaneously Administered rAvPAL-PEG in Patients With Phenylketonuria for 24 Weeks Phase 2