Compounds > edaravone
Page last updated: 2024-10-30

edaravone and Liver Dysfunction

edaravone has been researched along with Liver Dysfunction in 6 studies

Research Excerpts

ExcerptRelevanceReference
"Two studies were conducted to assess the pharmacokinetic (PK) properties and tolerability of edaravone in Japanese subjects with mild to moderate hepatic impairment or normal hepatic functioning (study 1), and in white subjects with severe hepatic impairment compared to subjects with normal hepatic functioning (study 2)."2.94Open-label, Single-dose Studies of the Pharmacokinetics of Edaravone in Subjects with Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects with Normal Hepatic Functioning. ( Akimoto, M; Greis, T; Kakubari, M; Kondo, K; Nakamaru, Y; Todorovic, V; Yoshida, K, 2020)
"Edaravone was intravenously administered to rats just before reperfusion and partial (70%) hepatectomy was performed just after reperfusion."1.34Amelioration of hepatic ischemia/reperfusion injury in the remnant liver after partial hepatectomy in rats. ( Hiranuma, S; Horikawa, S; Ito, K; Koike, Y; Noda, Y; Ozasa, H, 2007)
"Antipyrine clearance was closely correlated to liver weight (r = 0."1.27Antipyrine metabolism during hepatic regeneration in the rat. ( Pilsgaard, H; Poulsen, HE, 1985)

Research

Studies (6)

TimeframeStudies, this research(%)All Research%
pre-19901 (16.67)18.7374
1990's0 (0.00)18.2507
2000's4 (66.67)29.6817
2010's0 (0.00)24.3611
2020's1 (16.67)2.80

Authors

AuthorsStudies
Nakamaru, Y1
Kakubari, M1
Yoshida, K1
Akimoto, M1
Todorovic, V1
Greis, T1
Kondo, K1
Tada, S1
Nakamoto, N1
Kameyama, K1
Tsunematsu, S1
Kumagai, N1
Saito, H1
Ishii, H1
Ninomiya, M1
Shimada, M1
Harada, N1
Soejima, Y1
Suehiro, T1
Maehara, Y1
Taniguchi, M1
Uchinami, M1
Doi, K1
Yoshida, M1
Sasaki, H1
Tamagawa, K1
Horiuchi, T1
Tanaka, K1
Hiranuma, S1
Ito, K1
Noda, Y1
Ozasa, H1
Koike, Y1
Horikawa, S1
Poulsen, HE1
Pilsgaard, H1

Clinical Trials (2)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MCI-186 in Subjects With Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function[NCT03664544]Phase 112 participants (Actual)Interventional2018-11-06Completed
A Multi-Center, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MCI-186 in Subjects With Mild or Moderate Hepatic Impairment Compared to Subjects With Normal Hepatic Function[NCT03289234]Phase 122 participants (Actual)Interventional2016-11-16Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Pharmacokinetic Parameters of MCI-186: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-∞)

Unchanged MCI-186 (NCT03664544)
Timeframe: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)

Interventionh*ng/mL (Mean)
HP PK MCI-186496.98
NHV PK MCI-186416.34

Pharmacokinetic Parameters of MCI-186: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last)

Unchanged MCI-186 (NCT03664544)
Timeframe: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)

Interventionh*ng/mL (Mean)
HP PK MCI-186473.90
NHV PK MCI-186394.65

Pharmacokinetic Parameters of MCI-186: Half-life (t½)

Unchanged MCI-186 (NCT03664544)
Timeframe: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)

Interventionh (Mean)
HP PK MCI-1863.88
NHV PK MCI-1869.51

Pharmacokinetic Parameters of MCI-186: Mean Residence Time (MRT)

Unchanged MCI-186 (NCT03664544)
Timeframe: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)

Interventionh (Mean)
HP PK MCI-1862.27
NHV PK MCI-1865.51

Pharmacokinetic Parameters of MCI-186: Peak Drug Concentration (Cmax)

Unchanged MCI-186 (NCT03664544)
Timeframe: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)

Interventionng/mL (Mean)
HP PK MCI-186347.6
NHV PK MCI-186280.3

Pharmacokinetic Parameters of MCI-186: Terminal Elimination Rate Constant (λZ)

Unchanged MCI-186 (NCT03664544)
Timeframe: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)

Intervention/h (Mean)
HP PK MCI-1860.19
NHV PK MCI-1860.15

Pharmacokinetic Parameters of MCI-186: Time to Reach Peak Concentration (Tmax)

Unchanged MCI-186 (NCT03664544)
Timeframe: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)

Interventionh (Median)
HP PK MCI-1861.02
NHV PK MCI-1861.02

Pharmacokinetic Parameters of MCI-186: Total Clearance (CL)

Unchanged MCI-186 (NCT03664544)
Timeframe: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)

InterventionL/h (Mean)
HP PK MCI-18666.82
NHV PK MCI-18678.72

Pharmacokinetic Parameters of MCI-186: Unbound Area Under the Concentration-time Curve From Time Zero to Infinity (AUCu0-∞)

Unchanged MCI-186 (NCT03664544)
Timeframe: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)

Interventionh*ng/mL (Mean)
HP PK MCI-18665.41
NHV PK MCI-18645.33

Pharmacokinetic Parameters of MCI-186: Unbound Total Clearance (Clu)

Unchanged MCI-186 (NCT03664544)
Timeframe: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)

InterventionL/h (Mean)
HP PK MCI-186529.83
NHV PK MCI-186702.10

Pharmacokinetic Parameters of MCI-186: Volume of Distribution at Steady State (Vss)

Unchanged MCI-186 (NCT03664544)
Timeframe: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)

InterventionL (Mean)
HP PK MCI-186133.86
NHV PK MCI-186449.79

Pharmacokinetic Parameters of MCI-186: Volume of Distribution During the Terminal Phase (VZ)

Unchanged MCI-186 (NCT03664544)
Timeframe: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)

InterventionL (Mean)
HP PK MCI-186359.85
NHV PK MCI-1861064.88

Incidence of Adverse Events (AEs) and Serious Adverse Events

Number of adverse events (NCT03664544)
Timeframe: Day -1 to Day 7

,
InterventionEvents (Number)
Adverse eventsSerious adverse eventsTreatment emergent adverse eventsAdverse Drug reactionTEAE leading to discontinuation of study drug
HP PK MCI-18600000
NHV PK MCI-18610110

AUC0-∞

(NCT03289234)
Timeframe: pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose

Interventionng*hr/mL (Mean)
Mild Hepatic Impairment727.55
Moderate Hepatic Impairment751.52
Normal Hepatic Function594.96

AUC0-last

(NCT03289234)
Timeframe: pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose

Interventionng*hr/mL (Mean)
Mild Hepatic Impairment716.86
Moderate Hepatic Impairment739.28
Normal Hepatic Function582.89

Cmax

(NCT03289234)
Timeframe: pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose

Interventionng/mL (Mean)
Mild Hepatic Impairment538.1
Moderate Hepatic Impairment533.4
Normal Hepatic Function429

t½

(NCT03289234)
Timeframe: pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose

Interventionhour (Mean)
Mild Hepatic Impairment3.14
Moderate Hepatic Impairment4.37
Normal Hepatic Function5.41

Trials

1 trial available for edaravone and Liver Dysfunction

ArticleYear
Open-label, Single-dose Studies of the Pharmacokinetics of Edaravone in Subjects with Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects with Normal Hepatic Functioning.
    Clinical therapeutics, 2020, Volume: 42, Issue:8

    Topics: Adolescent; Adult; Aged; Area Under Curve; Bradycardia; Edaravone; Female; Free Radical Scavengers;

2020
Open-label, Single-dose Studies of the Pharmacokinetics of Edaravone in Subjects with Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects with Normal Hepatic Functioning.
    Clinical therapeutics, 2020, Volume: 42, Issue:8

    Topics: Adolescent; Adult; Aged; Area Under Curve; Bradycardia; Edaravone; Female; Free Radical Scavengers;

2020
Open-label, Single-dose Studies of the Pharmacokinetics of Edaravone in Subjects with Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects with Normal Hepatic Functioning.
    Clinical therapeutics, 2020, Volume: 42, Issue:8

    Topics: Adolescent; Adult; Aged; Area Under Curve; Bradycardia; Edaravone; Female; Free Radical Scavengers;

2020
Open-label, Single-dose Studies of the Pharmacokinetics of Edaravone in Subjects with Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects with Normal Hepatic Functioning.
    Clinical therapeutics, 2020, Volume: 42, Issue:8

    Topics: Adolescent; Adult; Aged; Area Under Curve; Bradycardia; Edaravone; Female; Free Radical Scavengers;

2020

Other Studies

5 other studies available for edaravone and Liver Dysfunction

ArticleYear
Clinical usefulness of edaravone for acute liver injury.
    Journal of gastroenterology and hepatology, 2003, Volume: 18, Issue:7

    Topics: Animals; Antipyrine; Apoptosis; Carbon Tetrachloride; Chemical and Drug Induced Liver Injury; Edarav

2003
The hydroxyl radical scavenger MCI-186 protects the liver from experimental cold ischaemia-reperfusion injury.
    The British journal of surgery, 2004, Volume: 91, Issue:2

    Topics: Animals; Antipyrine; Cold Temperature; Edaravone; Free Radical Scavengers; Hydroxyl Radical; Interle

2004
Edaravone reduces ischemia-reperfusion injury mediators in rat liver.
    The Journal of surgical research, 2007, Volume: 137, Issue:1

    Topics: Animals; Antipyrine; Aspartate Aminotransferases; E-Selectin; Edaravone; Free Radical Scavengers; Li

2007
Amelioration of hepatic ischemia/reperfusion injury in the remnant liver after partial hepatectomy in rats.
    Journal of gastroenterology and hepatology, 2007, Volume: 22, Issue:12

    Topics: Animals; Antipyrine; Edaravone; Free Radical Scavengers; Gene Expression Regulation; Hepatectomy; In

2007
Antipyrine metabolism during hepatic regeneration in the rat.
    Liver, 1985, Volume: 5, Issue:4

    Topics: Animals; Antipyrine; Edaravone; Female; Liver Diseases; Liver Regeneration; Organ Size; Rats; Rats,

1985