Delving into the Latest Updates on 13C-Methacetin(University of Texas Southwestern Medical Center) with Synapse

Overview

Basic Info

Drug Type

Chemical drugs, Diagnostic radiopharmaceuticals

Synonyms

N-(4-Methoxy-13C-phenyl)acetamide

Target-

Mechanism

PET imaging(Positron-emission tomography enhancers)

Therapeutic Areas

Digestive System Disorders

Active Indication

Decompensated cirrhosis of liver

Inactive Indication

Chemical and Drug Induced Liver InjuryComplicationEsophageal and Gastric Varices+ [8]

Originator Organization

University of Texas Medical Branch

Active Organization

Baylor College of Medicine

Conatus Pharmaceuticals, Inc.

Meridian Bioscience Israel Ltd.

Inactive Organization

Meridian Bioscience, Inc.

Hadassah University Hospital

Humedics GmbH

+ [1]

Drug Highest PhasePreclinical

First Approval Date-

Regulation-

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The ALFSG-MBT protocol is for a multicenter, open label, non-randomized study to determine the value of Breath Identification® (BreathID®) N-(4-Methoxy-13C-phenyl)acetamide (13C-Methacetin) Breath Test System in predicting the outcome of patients diagnosed with severe acute liver injury that is not related to acetaminophen overdose or acute liver failure who meet inclusion/exclusion criteria.
Up to 200 evaluable patients will be enrolled. An evaluable patient is one who has completed one or more breath tests for at least 30 minutes after administration of the 13C-Methacetin solution (test substrate).
The Breath Test will be performed up to five times during the study period on all enrolled patients. The first Breath Test will be performed upon admission into the study (Day 1) and repeated on Days 2, 3, 5 and 7 provided no contra-indications are present. Each test continuously measures changes in the metabolism of the 13C-Methacetin in order to assess the improvement or deterioration in liver metabolic function about improvement or deterioration in liver metabolic function. If an enrolled non-APAP ALI or ALF patient receives a liver transplant, is discharged /transferred from the hospital or dies prior to Day 7, additional Breath Tests will not be performed.
Patients will be contacted for the Day 21 follow up (21 days after enrollment into the trial) to determine spontaneous survival, transplantation and occurrence of serious adverse events since the patient's last study treatment.

Start Date10 Jun 2016

Sponsor / Collaborator

The University of Texas Southwestern Medical Center

[+4]

NCT02084160 / CompletedNot Applicable

The Prediction Value of the BreathID 13C-Methacetin Breath Test for Hepatic Decompensation; a Retrospective Analysis

The objectives of this study are:
To evaluate the ability of the Methacetin Breath Test (MBT) to detect hepatic decompensation events
To evaluate the relationship between liver Biopsy and clinical outcome and show that the MBT has a better predictive ability of clinical outcome than liver biopsy.
To evaluate the ability of the MBT to predict each of the individual liver related complications.

Start Date01 Mar 2014

Sponsor / Collaborator

Meridian Bioscience, Inc.

100 Clinical Results associated with 13C-Methacetin(University of Texas Southwestern Medical Center)

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100 Translational Medicine associated with 13C-Methacetin(University of Texas Southwestern Medical Center)

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100 Patents (Medical) associated with 13C-Methacetin(University of Texas Southwestern Medical Center)

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20

Literatures (Medical) associated with 13C-Methacetin(University of Texas Southwestern Medical Center)

01 Oct 2024·BIOGEOCHEMISTRY

Delineating acetaminophen biodegradation kinetics and metabolomics using bacterial community

Article

Author: Dubey, Suresh Kumar ; Pandey, Bhavana

Acetaminophen [N-(4-hydroxyphenyl) acetamide, APAP] is an extensively and frequently consumed over-the-counter analgesic and antiphlogistic medication. It is being regarded as an emerging pollutant due to its continuous increment in the environment instigating inimical impacts on humans and the ecosystem. Considering its wide prevalence in the environment, there is an immense need of appropriate methods for the removal of APAP. The present study indulged screening and isolation of APAP degrading bacterial strains from pharmaceuticals-contaminated sites, followed by their molecular characterization via 16S rRNA sequencing. The phylogenetic analyses assigned the isolates to the genera Pseudomonas, Bacillus, Paracoccus, Agrobacterium, Brucella, Escherichia, and Enterobacter based on genetic relatedness. The efficacy of these strains in batch cultures tested through High-performance Liquid Chromatography (HPLC) revealed Paracoccus sp. and Enterobacter sp. as the most promising bacterial isolates degrading up to 88.96 and 85.92%, respectively of 300 mg L^-1 of APAP within 8 days of incubation. Michaelis-Menten kinetics model parameters also elucidated the high degradation potential of these isolates. The major metabolites identified through FTIR and GC-MS analyses were 4-aminophenol, hydroquinone, and 3-hydroxy-2,4-hexadienedioic. Therefore, the outcomes of this comprehensive investigation will be of paramount significance in formulating strategies for the bioremediation of acetaminophen-contaminated sites through a natural augmentation process via native bacterial strains.

01 Jan 2022·Dose-response : a publication of International Hormesis SocietyQ4 · MEDICINE

The Potential Protective Effect of Curcumin and α-Lipoic Acid on N-(4-Hydroxyphenyl) Acetamide-induced Hepatotoxicity Through Downregulation of α-SMA and Collagen III Expression

Q4 · MEDICINE

ArticleOA

Author: Ali, Hanaa ; Badr, Amira ; Fadda, Laila ; Sarawi, Wedad ; Mahamad, Raeesa ; Hasan, Iman ; Alhusain, Ahlam ; Alomar, Hatun

Background and objectives:

N-(4-hydroxyphenyl) acetamide (NHPA) is the most commonly used analgesic and antipyretic agent worldwide; however, it remains the leading cause of drug-induced acute liver failure. This study explored the potential impact of curcumin (Curc) and/or α-lipoic acid (Lip acid) on liver damage induced by NHPA overdose.

Materials and Methods:

Male Wistar rats were intoxicated with a single oral dose of NHPA (1000 mg/kg) and treated with Curc (200 mg/kg p. o.) and/or Lip acid (100 mg/kg i. p.). These treatments were given in 2 doses at 2 hours and 10 hours post-NHPA-administration. Animals were sacrificed 24 hours post-NHPA-administration.

Results:

Treatment with Curc and/or Lip acid showed effective reduction of NHPA-induced liver injury, demonstrated by reducing serum alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin, as well as hepatic nitric oxide and malondialdehyde. Curc and/or Lip acid treatments counteracted these changes. They also ameliorated NHPA-induced centrilobular hepatocellular necrosis, evidenced by histopathological examination. Moreover, Curc and Lip acid reduced the expression of alpha-smooth muscle actin and collagen III, upregulated by NHPA intoxication in response to oxidative stress and inflammation.

Discussion and Conclusion:

Curc and Lip acid can be considered as promising natural therapies against liver injury, induced by NHPA, through their antioxidant and antifibrotic actions.

01 Sep 2018·European radiologyQ2 · MEDICINE

Gd-EOB-DTPA-enhanced T1 relaxometry for assessment of liver function determined by real-time 13C-methacetin breath test

Q2 · MEDICINE

Article

Author: Poelsterl, Stefanie ; Fuhrmann, Irene ; Verloh, Niklas ; Stroszczynski, Christian ; Nickel, Marcel D ; Wiggermann, Philipp ; Fellner, Claudia ; Dahlke, Marc H ; Weigand, Kilian ; Haimerl, Michael

OBJECTIVES:

To determine whether liver function as determined by intravenous administration of ¹³C-methacetin and continuous real-time breath analysis can be estimated quantitatively from gadoxetic acid (Gd-EOB-DTPA)-enhanced magnetic resonance (MR) relaxometry.

METHODS:

Sixty-six patients underwent a ¹³C-methacetin breath test (¹³C-MBT) for evaluation of liver function and Gd-EOB-DTPA-enhanced T1-relaxometry at 3 T. A transverse 3D VIBE sequence with an inline T1 calculation based on variable flip angles was acquired prior to (T1 pre) and 20 min post-Gd-EOB-DTPA (T1 post) administration. The reduction rate of T1 relaxation time (rrT1) and T1 relaxation velocity index (∆R1) between pre- and post-contrast images was evaluated. ¹³C-MBT values were correlated with T1_post, ∆R1 and rrT1, providing an MRI-based estimated ¹³C-MBT value. The interobserver reliability was assessed by determining the intraclass correlation coefficient (ICC).

RESULTS:

Stratified by three different categories of ¹³C-MBT readouts, there was a constant increase of T1 post with increasing progression of diminished liver function (p ≤ 0.030) and a constant significant decrease of ∆R1 (p ≤ 0.025) and rrT1 (p < 0.018) with progression of liver damage as assessed by ¹³C-methacetin breath analysis. ICC for all T1 relaxation values and indices was excellent (> 0.88). A simple regression model showed a log-linear correlation of ¹³C-MBT values with T1_post (r = 0.57; p < 0.001), ∆R1 (r = 0.59; p < 0.001) and rrT1 (r = 0.70; p < 0.001).

CONCLUSION:

Liver function as determined using real-time ¹³C-methacetin breath analysis can be estimated quantitatively from Gd-EOB-DTPA-enhanced MR relaxometry.

KEY POINTS:

• Gd-EOB-DTPA-enhanced T1 relaxometry quantifies liver function • Gd-EOB-DTPA-enhanced MR relaxometry may provide parameters for assessing liver function before surgery • Gd-EOB-DTPA-enhanced MR relaxometry may be useful for monitoring liver disease progression • Gd-EOB-DTPA-enhanced MR relaxometry has the potential to become a novel liver function index.

100 Deals associated with 13C-Methacetin(University of Texas Southwestern Medical Center)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chemical and Drug Induced Liver Injury	Phase 3	US	Meridian Bioscience, Inc.	10 Jun 2016
Chemical and Drug Induced Liver Injury	Phase 3	US	The University of Texas Southwestern Medical Center	10 Jun 2016
Liver Failure, Acute	Phase 3	US	The University of Texas Southwestern Medical Center	10 Jun 2016
Liver Failure, Acute	Phase 3	US	Meridian Bioscience, Inc.	10 Jun 2016
Pulmonary Disease, Chronic Obstructive	Phase 3	IL	Meridian Bioscience Israel Ltd.	30 Sep 2010
Hepatitis B, Chronic	Phase 3	IL	Hadassah University Hospital	17 Sep 2010
liver function failure	Phase 3	US	Meridian Bioscience Israel Ltd.	31 Mar 2010
liver function failure	Phase 3	IL	Meridian Bioscience Israel Ltd.	31 Mar 2010
Fibrosis	Phase 3	US	Meridian Bioscience Israel Ltd.	31 Aug 2008
Fibrosis	Phase 3	IL	Meridian Bioscience Israel Ltd.	31 Aug 2008

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03611101 (CTgov)	Not Applicable	Nonalcoholic Steatohepatitis	124	BreathID MCS device+BMS-986036+¹³C-Methacetin Breath Test	gyzrudtbtg(gsjxhzluoz) = gnqsuojwni ojctltnebe (lyhoknebxo, elmssrpgxk - wkvviawgtt) View more	-	09 Aug 2022
NCT02786836 (ALFSG-MBT, CTgov)	Phase 2/3	Chemical and Drug Induced Liver Injury \| Liver Failure, Acute	76	13C-Methacetin	pgstfihglu(jyjeoesjre) = cfsljvjzuq sxxkpnijmr (kofceggwwm, heeseubgbq - thnwuymmpp) View more	-	22 Dec 2020
EASL2020	Not Applicable	liver function failure	15	13C-methacetin	hdxoctaezt(ewxwogryuz) = cconelorly fekukxcoch (ayiveaxejm, 753 - 61)	-	27 Aug 2020