Phase 1
N=74
Study of Oral Edaravone in Healthy Adult Males
Healthy Adult Subjects
Bottom Line
View on ClinicalTrials.gov: NCT04481750 ↗Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Number of Participants With Adverse Events (Aes) and Adverse Drug Reactions (ADRs) — 0; 2; 3; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- MT-1186 (Drug); MT-1186-matching placebo (Drug)
- Age
- Adult · 20+ yrs
- Sex
- Male
- Sponsor
- Tanabe Pharma Corporation
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (Aes) and Adverse Drug Reactions (ADRs) |
0; 2; 3; 0; 0; 1 | — |
| PRIMARY Area Under the Concentration Versus Time Curve (AUC) of Unchanged Edaravone |
816; 2242; 6254; 2443; 11319; 9034 | — |
| PRIMARY Area Under the Concentration Versus Time Curve (AUC) of Sulfate Conjugate |
16251; 30004; 45666; 38244; 67693; 68126 | — |
| PRIMARY Area Under the Concentration Versus Time Curve (AUC) of Glucuronide Conjugate |
2360; 4815; 8146; 7406; 14403; 12499 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) of Unchanged Edaravone |
755; 1735; 4933; 899; 8805; 5426 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) of Sulfate Conjugate |
5481; 9108; 12190; 7324; 14590; 14080 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) of Glucuronide Conjugate |
1313; 2272; 3507; 1893; 5322; 3968 | — |
| PRIMARY Part 2: Minimum Plasma Concentration at Steady State (Ctrough, ss) |
2.34; 3.79; 32.91; 49.98; 2.69; 5.48 | — |
| PRIMARY Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone |
0.3; 0.4; 0.4; 1.4; 0.6; 0.8 | — |
| PRIMARY Time to Reach Maximum Plasma Concentration (Tmax) of Sulfate Conjugate |
0.6; 0.8; 1.0; 1.3; 1.3; 1.4 | — |
| PRIMARY Time to Reach Maximum Plasma Concentration (Tmax) of Glucuronide Conjugate |
0.5; 0.6; 0.6; 1.2; 1.0; 1.1 | — |
| PRIMARY Terminal Elimination Half-life (t1/2) of Unchanged Edaravone |
3.2; 5.1; 9.1; 5.2; 11.8; 9.1 | — |
| PRIMARY Terminal Elimination Half-life (t1/2) of Sulfate Conjugate |
7.9; 7.3; 5.9; 5.1; 6.0; 4.9 | — |
| PRIMARY Terminal Elimination Half-life (t1/2) of Glucuronide Conjugate |
3.4; 3.2; 4.3; 3.8; 5.9; 4.8 | — |
| PRIMARY Lambda-z of Unchanged Edaravone |
0.23; 0.14; 0.08; 0.14; 0.07; 0.08 | — |
| PRIMARY Lambda-z of Sulfate Conjugate |
0.10; 0.11; 0.12; 0.14; 0.12; 0.14 | — |
| PRIMARY Lambda-z of Glucuronide Conjugate |
0.23; 0.23; 0.17; 0.19; 0.12; 0.15 | — |
| PRIMARY Mean Residence Time (MRT) of Unchanged Edaravone |
1.92; 2.07; 1.98; 3.41; 2.14; 2.42 | — |
| PRIMARY Apparent Total Clearance (CL/F) of Unchanged Edaravone |
79.77; 60.29; 32.73; 87.07; 26.42; 36.11 | — |
| PRIMARY Apparent Distribution Volume at Elimination Phase (Vz/F) and Apparent Distribution Volume at Steady State (Vss/F) of Unchanged Edaravone |
348.98; 422.67; 426.49; 620.73; 457.99; 457.37 | — |
| SECONDARY Change of Heart Rate (HR) From Baseline |
1.8; -1.2; 1.8; -0.2; -0.2; 0.2 | — |
| SECONDARY Change of PR Interval (PR) From Baseline |
-6.8; -3.3; -5.7; -4.5; -4.2; 0.1 | — |
| SECONDARY Change of QTcF Interval (QTcF) From Baseline |
2.0; 0.7; 1.6; 0.8; -2.2; 1.1 | — |
| SECONDARY Change of QRS Duration (QRS) From Baseline |
-0.7; -0.4; 0.4; -2.0; -0.3; -0.8 | — |
Summary
To evaluate the pharmacokinetics safety, and tolerability of single and multiple doses of edaravone solution and suspension in healthy adult males
Eligibility Criteria
Inclusion Criteria
Additional screening criteria check may apply for qualification:
- Healthy adult male volunteers
- Japanese or Caucasian
- Subjects aged between 20 and 45 years at the time of informed consent
- Subjects who have thoroughly understood the contents of the study and voluntarily provided written informed consent to participate in the study
Exclusion Criteria
Additional screening criteria check may apply for qualification:
- Subjects with a current or previous history of cardiac, hepatic, renal, gastrointestinal, respiratory, psychiatric/nervous, hematopoietic, or endocrine diseases, and those whom the investigator (or subinvestigator) deems unsuitable for the study
- Body mass index (BMI) of 30.0, or body weight of <50 kg (BMI formula: body weight [kg]/height [m]2, rounded to one decimal place)
- Subjects who have undergone any surgery known to affect the gastrointestinal absorption of drugs
- Subjects who do not agree to use an effective method of contraception from initiation of study drug administration to 14 days after completion (discontinuation) of study drug administration
- Subjects who have previously received edaravone
- Subjects who have participated in another clinical study and received a study drug within 12 weeks before providing informed consent
Data sourced from ClinicalTrials.gov (NCT04481750). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.