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Sponsored by: |
BioMarin Pharmaceutical |
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Information provided by: | BioMarin Pharmaceutical |
ClinicalTrials.gov Identifier: | NCT00789568 |
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.
Condition | Intervention | Phase |
---|---|---|
Phenylketonuria |
Drug: sapropterin dihydrochloride |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Crossover Assignment, Safety Study |
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 |
Estimated Enrollment: | 56 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Screening, Check-in, or Baseline ECG shows any of the following:
Subjects who have taken:
Contact: Mari Maurer | 415-506-6700 | mmaurer@bmrn.com |
United States, North Dakota | |
PRACS Institute, Ltd. | Recruiting |
Fargo, North Dakota, United States, 58104 |
Study Director: | Don Nwose, MD | BioMarin Pharmaceutical |
Responsible Party: | BioMarin Pharmaceutical Inc. ( Oliseyenum (Don) Nwose, MD ) |
Study ID Numbers: | QTC-001 |
Study First Received: | November 10, 2008 |
Last Updated: | November 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00789568 |
Health Authority: | United States: Food and Drug Administration |
Hyperphenylalanemia due to Phenylketonuria |
Metabolic Diseases Amino Acid Metabolism, Inborn Errors Central Nervous System Diseases Healthy Brain Diseases Metabolism, Inborn Errors Inborn amino acid metabolism disorder |
Genetic Diseases, Inborn Phenylketonurias Brain Diseases, Metabolic, Inborn Metabolic disorder Phenylketonuria Brain Diseases, Metabolic |
Nervous System Diseases |