drugset / Trial / NCT02111200
Comparative Efficacy of Phenylbutyrate (PBA) vs. Benzoate in Urea Cycle Disorders
RandomizedCrossoverOpen-labelOther
Summary
The investigators will study and compare how effectively sodium phenylbutyrate, sodium benzoate, and a combination of the two, help excrete nitrogen in healthy volunteers. Subject participation will require three, separate, four-day study periods at least one week apart. During one study period (also called a treatment arm), subjects will take sodium phenylbutyrate; during another they will take sodium benzoate; during another they will take a combination of the two medications. We expect to find that phenylbutyrate is more effective at removing nitrogen than benzoate or a combination of the two.
Timeline
- Start
- 2014-09
- Primary completion
- 2015-10
- Completion
- 2015-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Sodium Benzoate | Small molecule | 2750 mg/m2 | — |
| Comparator | Sodium Benzoate | Small molecule | 5500 mg/m2 | — |
| Comparator | Sodium Phenylbutyrate | Small molecule | 3575 mg/m2 | — |
| Comparator | Sodium Phenylbutyrate | Small molecule | 7150 mg/m2 | — |