Clinical Trials Logo
  1. Home
  2. Other
  3. NCT04269122

A Study to Assess Plasma Ammonia Time-Normalized Area Under the Curve and Rate of Ureagenesis in Healthy Adult Subjects

Ornithine Transcarbamylase Deficiency Clinical Trial

Official title:
A Single-Center Study to Assess Plasma Ammonia Time-Normalized Area Under the Curve From Time Zero to 24 Hours and Rate of Ureagenesis in Healthy Adult Subjects

Clinical Trial Summary

The objective of the study is to characterize 24-hour plasma ammonia levels, characterize urea production rates in healthy normal subjects.

Clinical Trial Description

During Part 1, eligible subjects will be asked to participate in 3 inpatient visits, each lasting up to 3 days (Day -1 to Day 2). Each visit will assess 24-hour ammonia levels in plasma and rate of urea production for 4 hours following ingestion of [1-13C]sodium acetate. Sodium acetate is used as a tracer to measure the rate of ureagenesis.

During Part 2, eligible subjects will be asked to participate in 1 inpatient visit, lasting up to 3 days (Day -1 to Day 2). The visit will assess 24-hour ammonia levels in plasma and rate of urea production for 4 hours following ingestion of [1-13C]sodium acetate. Sodium acetate is used as a tracer to measure the rate of ureagenesis. ;

Study Design

Related Conditions & MeSH terms

  • Ornithine Transcarbamylase Deficiency
Clinical Trial Details
NCT number NCT04269122
Study type Observational
Source Ultragenyx Pharmaceutical Inc
Contact
Status Completed
Phase
Start date August 2, 2019
Completion date February 20, 2020
View Details
See also
  Status Clinical Trial Phase
Completed NCT01569568 - Investigation of Brain Nitrogen in Partial Ornithine Transcarbamylase Deficiency (OTCD) Using 1 H MRS, DTI, and fMRI
Recruiting NCT05687474 - Baby Detect : Genomic Newborn Screening
Terminated NCT04717453 - Study to Characterize Rate of Ureagenesis in Patients With Ornithine Transcarbamylase (OTC) Deficiency
Recruiting NCT05910151 - Selective Screening of Children for Hereditary Metabolic Diseases by Tandem Mass Spectrometry in Kazakhstan
Enrolling by invitation NCT03655223 - Early Check: Expanded Screening in Newborns
Recruiting NCT04612764 - Liver Disease in Urea Cycle Disorders
Active, not recruiting NCT04442347 - Phase 1b Study to Assess Safety, Tolerability, and Pharmacokinetics of ARCT-810 in Stable Adult Subjects With Ornithine Transcarbamylase Deficiency Phase 1
Not yet recruiting NCT02670889 - Urease Inhibitor Drug Treatment for Urea Cycle Disorders Phase 1/Phase 2
Recruiting NCT05092685 - Halting Ornithine Transcarbamylase Deficiency With Recombinant AAV in ChildrEn Phase 1/Phase 2
Completed NCT00472732 - Neurologic Injuries in Adults With Urea Cycle Disorders N/A
Terminated NCT04909346 - Adeno-Associated Virus (AAV) Antibody Study in Subjects OTC Deficiency, GSDIa, and Wilson Disease
Completed NCT04416126 - Safety, Tolerability and Pharmacokinetics of ARCT-810 in Healthy Adult Subjects Phase 1
Recruiting NCT05526066 - Study for Adolescent and Adult Participants With Ornithine Transcarbamylase Deficiency to Evaluate Safety and Tolerability of ARCT-810 Phase 2
Completed NCT00718627 - Human Heterologous Liver Cells for Infusion in Children With Urea Cycle Disorders Phase 2
Recruiting NCT04908319 - Hepatic Histopathology in Urea Cycle Disorders
Withdrawn NCT03767270 - Safety, Tolerability and PK/PD Evaluation of Intravenous Administration of MRT5201 in Patients With OTC Deficiency Phase 1/Phase 2
Recruiting NCT06255782 - An Open-label Study to Investigate ECUR-506 in Male Babies Less Than 9 Months of Age With Neonatal Onset OTC Deficiency (OTC-HOPE) Phase 1/Phase 2