Hepatic Insufficiency Clinical Trial
Official title:
Mitochondrial Function in Patients With Severe Liver Disease
The researchers will recruit patients with liver disease at Parkland Hospital. Patients will fast overnight, and the next morning will receive an oral mixture of [U-13C3]glycerol (25 mg/kg) plus unlabeled glycerol (25 mg/kg). The total dose of glycerol will be 50 mg/kg in 100 milliliters of water. The taste is slightly sweet. Blood will be drawn at 60 min and 120 min after the ingestion. Blood glucose will be isolated and analyzed by NMR. The presence of [5,6-13C2]- and [4,5-13C2]glucose indicates preserved mitochondrial function. The researchers anticipate that patients with severe liver disease will show a decrease in mitochondrial function and will inform biosynthetic function of liver mitochondria. After the first 6 successful exams (see power analysis, below), healthy volunteers (age-, gender-, and race-matched) will be studied at the AIRC and subject to the same protocol.
The researchers will recruit patients with severe liver disease at Parkland Hospital where the procedure will be performed. Age-, gender- and race-matched healthy subjects will be recruited from general population, and the procedure will be performed at the procedure room of the AIRC. Patients at Parkland will be screened and selected by Dr. Jeffrey Browning and Dr. Rodney Infante. After ingestion of 25 mg/kg [U-13C3]glycerol plus 25 mg/kg unlabeled glycerol in water (total glycerol dose, 50 mg/kg), blood will be drawn at +60 and +120 min. Healthy subjects will make two visits to the AIRC for screening and study procedures. The screening visit will take an hour and the study visit will take 3 hours. Volunteers will be made comfortable in the procedure room of the Research Center. All the study procedures at both Parkland and AIRC will be under the direction of the principal investigator, Dr. Jeffrey Browning. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04097704 -
Pharmacogenetics Sampling of the CC-90007-CP-003 Study Cohort
|
||
Completed |
NCT02161224 -
A Study to Investigate the Exposure and Safety and Tolerability of a Single Dose of FG-4592 in Subjects With Moderately Diminished Liver Function Compared to Those With Normal Liver Function
|
Phase 1 | |
Completed |
NCT00929032 -
Liver Transplantation and Reticuloendothelial Clearance Capacity
|
N/A | |
Completed |
NCT00509210 -
Study of Telaprevir in Subjects With Hepatic Impairment
|
Phase 1 | |
Completed |
NCT02894385 -
Effect of Hepatic and Renal Impairment on the Pharmacokinetics, Safety and Tolerability of BAY1841788 (ODM-201)
|
Phase 1 | |
Completed |
NCT03306667 -
Clinical Pharmacology of FYU-981 (Subjects With Hepatic Insufficiency)
|
Phase 1 | |
Completed |
NCT04867941 -
A Study to Evaluate the Effect of Hepatic Insufficiency on the Pharmacokinetics (PK) of ACP-196
|
Phase 1 | |
Completed |
NCT02090621 -
Extracorporeal Photopheresis After Liver Transplant
|
Phase 2 | |
Completed |
NCT02249442 -
Study to Determine the Pharmacokinetics on TPV/r in Subjects With Mild and Moderate Hepatic Insufficiency
|
Phase 1 | |
Completed |
NCT03341884 -
A Study of Ipatasertib in Participants With Mild, Moderate or Severe Hepatic Impairment Compared to Healthy Participants
|
Phase 1 | |
Completed |
NCT01475136 -
A Study of LY2140023 in Hepatically-Impaired Participants
|
Phase 1 | |
Completed |
NCT00969813 -
A Safety and Tolerability Study of CP-690,550 in Subjects With Hepatic Impairment and Normal Hepatic Function
|
Phase 1 | |
Completed |
NCT00968591 -
Pharmacokinetics of Everolimus in Subjects With Hepatic Insufficiency
|
Phase 1 | |
Completed |
NCT00931060 -
Effects of Branched-Chain Amino Acids on Muscle Ammonia Metabolism in Patients With Cirrhosis and Healthy Subjects
|
N/A | |
Completed |
NCT00416702 -
Safety and Pharmacokinetics of Indacaterol in Healthy Subjects and Those With Impaired Liver Function
|
Phase 1 | |
Completed |
NCT03968848 -
Investigate the Influence of Severe Hepatic Impairment on the Pharmacokinetics of Acalabrutinib and Its Metabolite
|
Phase 1 | |
Completed |
NCT00692341 -
Evaluation Of Hepatic Impairment On AG-013736 Pharmacokinetics
|
Phase 1 | |
Completed |
NCT00314054 -
Study Evaluating the Safety of HCV-796 in Subjects With Liver Disease and in Healthy Adults
|
Phase 1 | |
Completed |
NCT05731895 -
A Study to Test How Iclepertin is Taken up in the Blood of People With and Without Liver Problems
|
Phase 1 | |
Completed |
NCT03842761 -
A Study to Test How Different Doses of BI 685509 Are Tolerated in Patients With Liver Problems
|
Phase 1 |