Study to Evaluate 13 C Isotope Ratio Measurement for Urea Cycle Capacity Assessment
In this short-term study a method for the evaluation of the metabolic competency of the urea cycle in vivo will be assessed. In order to monitor the efficacy of new treatment options for patients with urea cycle disorders and to monitor the severity of the disease, a reliable and safe quantitative method for the measurement of the urea cycle flux is required.
Urea synthesis will be evaluated by administering sodium [1-13C]-acetate and measuring subsequent incorporation of [13C] label from Na-acetate into urea in healthy volunteers and asymptomatic subjects genetically disposed to urea cycle disorders.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Pilot Feasibility Study in Healthy Subjects and Healthy Asymptomatic Subjects Genetically Disposed to Urea Cycle Disorders to Evaluate the Use of 13 C Isotope Ratio Measurement|
- Increase of [13C]urea AUC in plasma following oral administration of [13C ]-sodium acetate over baseline [ Designated as safety issue: No ]
- Cmax of absolute [13C]urea in plasma [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Study Completion Date:||December 2009|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
|CRS Clinical Research Services Mönchengladbach GmbH|
|Mönchengladbach, Germany, 41061|
|Principal Investigator:||Doris Neuenhofer, MD||CRS Clinical Research Services Mönchengladbach GmbH|