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| Name | Class |
|---|---|
| Ocera Therapeutics | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| phenylacetate salt of ornithine | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| phenylacetate salt of ornithine | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| metabolism of ornithine phenylacetate to glutamate and glutamine | 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. | 4 study days that are 8 hours each |
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Inclusion criteria healthy subjects:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Marielle Engelen, PhD | Texas A&M University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas A&M University-CTRAL | College Station | Texas | 77843-4253 | United States |
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