Metabolism of Ornithine Phenylacetate (OCERA OP)
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|ClinicalTrials.gov Identifier: NCT03159390|
Recruitment Status : Unknown
Verified April 2019 by Marielle PKJ Engelen, PhD, Texas A&M University.
Recruitment status was: Active, not recruiting
First Posted : May 18, 2017
Last Update Posted : April 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Other: phenylacetate salt of ornithine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Human Metabolism of Ornithine Phenylacetate: A Study in Healthy Volunteers|
|Actual Study Start Date :||February 2015|
|Actual Primary Completion Date :||April 2015|
|Estimated Study Completion Date :||April 2021|
Experimental: phenylacetate salt of ornithine
There are 4 study days of approximately 10 hours. Amino acid tracers (e.g., OP, PHE, TYR) will be provided via IV. The dosage of OP provided in this study 6 g in a period of 6 hours. 2 muscle biopsies will be completed on 2 of the study days.
Other: phenylacetate salt of ornithine
- metabolism of ornithine phenylacetate to glutamate and glutamine [ Time Frame: 4 study days that are 8 hours each ]The incorporation of the N atoms of ORN into glutamate, and the quantitative contribution of both pathways will be traced, and when the enrichment of ORN and GLU is measured in muscle tissue, give an estimation of the importance of muscle OAT for this incorporation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03159390
|United States, Texas|
|Texas A&M University-CTRAL|
|College Station, Texas, United States, 77843-4253|
|Principal Investigator:||Marielle Engelen, PhD||Texas A&M University|