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A Phase 2 Randomized Open-label 2-Treatment 2-Sequence 2-Period Crossover PK Study to Compare Plasma Concentrations of BH4 in Subjects With Endothelial Dysfunction Following 14 Days of Treatment by 2 Regimens: 6R-BH4 With Vitamin C and 6R-BH4 Alone
This Phase 2, randomized, open-label, 2-treatment, 2-sequence, 2-period crossover, pharmacokinetic (PK) study will compare plasma concentrations of BH4 in subjects with endothelial dysfunction following 14 days of treatment by each of 2 regimens: sapropterin dihydrochloride with vitamin C and sapropterin dihydrochloride alone.
Details
| Lead sponsor | BioMarin Pharmaceutical |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 52 |
| Start date | 2007-09 |
| Completion | 2009-03 |
Conditions
- Endothelial Dysfunction
Interventions
- Sapropterin Dihydrochloride
- Sapropterin Dihydrochloride and Vitamin C
Primary outcomes
- Area Under the Curve (AUC0-12hrs) of Plasma BH4 Concentration — At 30 minutes prior to dosing, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 6.0, 8.0, 10.0, and 12.0 hours after dosing.
Plasma BH4 concentration area under the curve (AUC0-12 hrs) at the end of each regimen in subjects with endothelial dysfunction.
Countries
United States