Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00789568 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Study to Evaluate Effects of Sapropterin Dihydrochloride on QTc Intervals in Healthy Adult Subjects
A Phase 1 study of Phenylketonuria, sponsored by BioMarin Pharmaceutical.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
- 1
- Study location
NCT00789568: Completed Phase 1 study of Phenylketonuria, sponsored by BioMarin Pharmaceutical.
NCT00789568 is a Phase 1 study of Phenylketonuria that has completed, run by BioMarin Pharmaceutical. The registered enrollment target is 56 participants, below the 94-participant average among 12 other Phenylketonuria trials with a reported enrollment target (40% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00789568, a Phase 1 study of Phenylketonuria, has completed, sponsored by BioMarin Pharmaceutical.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Moxifloxacin
- DRUG Moxifloxacin placebo
- DRUG sapropterin dihydrochloride
Study Locations (1)
North Dakota
- PRACS Institute, Ltd. - Fargo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2008-10 |
| Est. Completion | 2009-10 |
| Phase | Phase 1 |
What the finished NCT00789568 record still lists
NCT00789568 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 94-participant average among 12 other Phenylketonuria trials with a reported enrollment target (40% lower).
The record links to 1 condition, with Phenylketonuria appearing as the primary indexed condition, and to 3 interventions - of which Moxifloxacin is the first listed.
NCT00789568 reports a single indexed study location in North Dakota.
Frequently Asked Questions
What is clinical trial NCT00789568 about?
NCT00789568 is a clinical study titled "A Phase 1 Study to Evaluate Effects of Sapropterin Dihydrochloride on QTc Intervals in Healthy Adult Subjects". 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 (Kuv...
What is the current status of trial NCT00789568?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2008-10. Estimated completion is 2009-10.
What conditions does trial NCT00789568 study?
This clinical trial studies the following conditions: Phenylketonuria.
What interventions are being tested in trial NCT00789568?
The interventions under investigation include: Moxifloxacin (DRUG), Moxifloxacin placebo (DRUG), sapropterin dihydrochloride (DRUG).
Who is sponsoring clinical trial NCT00789568?
This trial is sponsored by BioMarin Pharmaceutical, which has 80 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00789568 being conducted?
This trial has 1 study location across North Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Phenylketonuria
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00789568's enrollment target sits among peer trials
56 7th of 12 higher than 5 of 12 other Phenylketonuria trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phenylketonuria trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Phase 1/Phase 2 Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of a Single Intravenous Administration of SAR444836 in Adult Participants With Phenylketonuria
ACTIVE NOT RECRUITING · Phase 1
-
First-in-Human, Multiple Part Clinical Study of JNT-517 in Healthy Participants and in Participants With Phenylketonuria
ACTIVE NOT RECRUITING · Phase 1
-
A Study to Evaluate the Safety and Efficacy of JNT-517 in Participants With Phenylketonuria (PKU)
RECRUITING · Phase 3
-
Educational, Social Support, and Nutritional Interventions and Their Cumulative Effect on Pregnancy Outcomes and Quality of Life in Teen and Adult Women With Phenylketonuria
RECRUITING · NA
-
A Study of Sepiapterin in Participants With Phenylketonuria (PKU)
RECRUITING · Phase 3
-
Rapid Drug Desensitization Study in Adults Experiencing Hypersensitivity Reactions to Palynziq
RECRUITING · Phase 4
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02287428 · 56 participants · Phase 1
Personalized NeoAntigen Cancer Vaccine w RT Plus Pembrolizumab for Patients With Newly Diagnosed GBM
- NCT02923011 · 56 participants · Phase 3
Comparative Effectiveness of MRgFUS Versus CTgRFA for Osteoid Osteomas
- NCT02935283 · 56 participants
Neuroimaging and Neuropsychological Outcomes in Urea Cycle Disorders
- NCT03375866 · 56 participants · NA
Effects of Mixed Nut Consumption on Satiety and Weight Management
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia