drugset / Trial / NCT02111200

Comparative Efficacy of Phenylbutyrate (PBA) vs. Benzoate in Urea Cycle Disorders

NCT02111200

Completed 7 enrolled Baylor College of Medicine
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

EvaluationDrugModalityDoseRoute
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

Indications