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NCT01002469 Clinical Trial

Study to Evaluate 13 C Isotope Ratio Measurement for Urea Cycle Capacity Assessment

Urea Cycle Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01002469
Other study ID # CCD07
Secondary ID
Status Completed
Phase N/A
First received October 26, 2009
Last updated January 14, 2010
Start date September 2009
Est. completion date December 2009

Study information
Verified date January 2010
Source Cytonet GmbH & Co. KG
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date December 2009
Est. primary completion date November 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Group 1 + 2: Healthy subjects

- Group 3: Healthy asymptomatic subjects genetically disposed to urea cycle disorders

- All: age 18 to 50 years (adult)

- Written informed consent

Exclusion Criteria:

- Presence of acute infection

- Participation in other clinical trials within 30 days prior to inclusion

- Severe coagulopathy

- Severe systemic or chronic disease

- Pregnancy or lactation

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Other:
• sodium [1-13C] acetate

Locations
Country Name City State
Germany CRS Clinical Research Services Mönchengladbach GmbH Mönchengladbach

Sponsors (1)
Lead Sponsor Collaborator
Cytonet GmbH & Co. KG

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Increase of [13C]urea AUC in plasma following oral administration of [13C ]-sodium acetate over baseline No
Secondary Cmax of absolute [13C]urea in plasma No
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