NCT03159390

Metabolism of Ornithine Phenylacetate

Human Metabolism of Ornithine Phenylacetate: A Study in Healthy Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Texas A&M University · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Intravenous infusion of stable tracers of ornithine, glutamine, glutamate, and glycine will be performed, and collect blood samples, urine samples, and muscle biopsies to evaluate the effect of a continuous oral intake of phenylacetate salt of ornithine (OP) on its metabolic fate.

Detailed description

The study involves 1 screening visit of approximately 1 hour and 4 study days of approximately 10 hours. The subject will be asked to arrive in the fasted state on all study days. Fasting prior to screening is not required. On the screening day, body weight and height will be measured and Dual-energy X-ray absorptiometry (DXA) will be performed to measure body composition. After 4 hours subjects received a continuous intravenous infusion with OP in a dosage of 1 g /h. Next to the stable tracers provided to determine OP metabolism, stable tracers of phenylalanine (PHE) and tyrosine (TYR) may be provided to determine the effect of OP on protein metabolism at plasma and muscle tissue level. This required 2 muscle biopsies and on 2 study days 1 set of stable tracer pulses.

Conditions

• Healthy

Interventions

Type	Name	Description
OTHER	phenylacetate salt of ornithine

Timeline

• Start date: 2015-02-03
• Primary completion: 2015-04-30
• Completion: 2015-04-30
• First posted: 2017-05-18
• Last updated: 2025-09-30

Locations

1 site across 1 country: United States