Page last updated: 2024-10-30
edaravone and Bradyarrhythmia
edaravone has been researched along with Bradyarrhythmia in 2 studies
Research Excerpts
| Excerpt | Relevance | Reference |
|---|
| "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)." | 2.94 | 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. ( Akimoto, M; Greis, T; Kakubari, M; Kondo, K; Nakamaru, Y; Todorovic, V; Yoshida, K, 2020) |
Research
Studies (2)
| Timeframe | Studies, this research(%) | All Research% |
|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 0 (0.00) | 29.6817 |
| 2010's | 1 (50.00) | 24.3611 |
| 2020's | 1 (50.00) | 2.80 |
Authors
| Authors | Studies |
|---|
| Nakamaru, Y | 1 |
| Kakubari, M | 1 |
| Yoshida, K | 1 |
| Akimoto, M | 1 |
| Todorovic, V | 1 |
| Greis, T | 1 |
| Kondo, K | 1 |
| Xin, Y | 1 |
| Zhang, S | 1 |
| Gu, L | 1 |
| Liu, S | 1 |
| Gao, H | 1 |
| You, Z | 1 |
| Zhou, G | 1 |
| Wen, L | 1 |
| Yu, J | 1 |
| Xuan, Y | 1 |
Clinical Trials (2)
Trial Overview
| Trial | Phase | Enrollment | Study Type | Start Date | Status |
|---|
| 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 1 | 12 participants (Actual) | Interventional | 2018-11-06 | Completed |
| 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 1 | 22 participants (Actual) | Interventional | 2016-11-16 | Completed |
| [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)
| Intervention | h*ng/mL (Mean) |
|---|
| HP PK MCI-186 | 496.98 |
| NHV PK MCI-186 | 416.34 |
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)
| Intervention | h*ng/mL (Mean) |
|---|
| HP PK MCI-186 | 473.90 |
| NHV PK MCI-186 | 394.65 |
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)
| Intervention | h (Mean) |
|---|
| HP PK MCI-186 | 3.88 |
| NHV PK MCI-186 | 9.51 |
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)
| Intervention | h (Mean) |
|---|
| HP PK MCI-186 | 2.27 |
| NHV PK MCI-186 | 5.51 |
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)
| Intervention | ng/mL (Mean) |
|---|
| HP PK MCI-186 | 347.6 |
| NHV PK MCI-186 | 280.3 |
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-186 | 0.19 |
| NHV PK MCI-186 | 0.15 |
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)
| Intervention | h (Median) |
|---|
| HP PK MCI-186 | 1.02 |
| NHV PK MCI-186 | 1.02 |
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)
| Intervention | L/h (Mean) |
|---|
| HP PK MCI-186 | 66.82 |
| NHV PK MCI-186 | 78.72 |
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)
| Intervention | h*ng/mL (Mean) |
|---|
| HP PK MCI-186 | 65.41 |
| NHV PK MCI-186 | 45.33 |
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)
| Intervention | L/h (Mean) |
|---|
| HP PK MCI-186 | 529.83 |
| NHV PK MCI-186 | 702.10 |
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)
| Intervention | L (Mean) |
|---|
| HP PK MCI-186 | 133.86 |
| NHV PK MCI-186 | 449.79 |
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)
| Intervention | L (Mean) |
|---|
| HP PK MCI-186 | 359.85 |
| NHV PK MCI-186 | 1064.88 |
Incidence of Adverse Events (AEs) and Serious Adverse Events
Number of adverse events (NCT03664544)
Timeframe: Day -1 to Day 7
| Intervention | Events (Number) |
|---|
| Adverse events | Serious adverse events | Treatment emergent adverse events | Adverse Drug reaction | TEAE leading to discontinuation of study drug |
|---|
| HP PK MCI-186 | 0 | 0 | 0 | 0 | 0 |
,| NHV PK MCI-186 | 1 | 0 | 1 | 1 | 0 |
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
| Intervention | ng*hr/mL (Mean) |
|---|
| Mild Hepatic Impairment | 727.55 |
| Moderate Hepatic Impairment | 751.52 |
| Normal Hepatic Function | 594.96 |
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
| Intervention | ng*hr/mL (Mean) |
|---|
| Mild Hepatic Impairment | 716.86 |
| Moderate Hepatic Impairment | 739.28 |
| Normal Hepatic Function | 582.89 |
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
| Intervention | ng/mL (Mean) |
|---|
| Mild Hepatic Impairment | 538.1 |
| Moderate Hepatic Impairment | 533.4 |
| Normal Hepatic Function | 429 |
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
| Intervention | hour (Mean) |
|---|
| Mild Hepatic Impairment | 3.14 |
| Moderate Hepatic Impairment | 4.37 |
| Normal Hepatic Function | 5.41 |
Trials
1 trial available for edaravone and Bradyarrhythmia
| Article | Year |
|---|
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
1 other study available for edaravone and Bradyarrhythmia