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

Cytonet GmbH & Co. KG10 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Urea Cycle Disorders

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

CRS Clinical Research Services Mönchengladbach GmbH

Mönchengladbach, Germany

Outcomes

Primary Outcomes

Increase of [13C]urea AUC in plasma following oral administration of [13C ]-sodium acetate over baseline

Secondary Outcomes

Cmax of absolute [13C]urea in plasma

Data from ClinicalTrials.gov

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