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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00789568
The ClinicalTrials.gov registry entry for NCT00789568 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 94-participant average among 12 other Phenylketonuria trials with a reported enrollment target (40% lower). The listed sponsor is BioMarin Pharmaceutical, which has 80 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
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