# A Study of the Safety, Efficacy and Pharmacokinetics of Glycerol Phenylbutyrate in Pediatric Subjects Under 2 Years of Age With Urea Cycle Disorders

> **NCT02246218** · PHASE4 · COMPLETED · sponsor: **Amgen** · enrollment: 27 (actual)

## Conditions studied

- Urea Cycle Disorder

## Interventions

- **DRUG:** RAVICTI

## Key facts

- **NCT ID:** NCT02246218
- **Lead sponsor:** Amgen
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE4
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2014-12-31
- **Primary completion:** 2016-10-17
- **Final completion:** 2017-07-17
- **Target enrollment:** 27 (ACTUAL)
- **Last updated:** 2024-07-01


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02246218

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02246218, "A Study of the Safety, Efficacy and Pharmacokinetics of Glycerol Phenylbutyrate in Pediatric Subjects Under 2 Years of Age With Urea Cycle Disorders". Retrieved via AI Analytics 2026-06-26 from https://api.ai-analytics.org/clinical/NCT02246218. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*