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Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Renal Impairment

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ClinicalTrials.gov Identifier: NCT03289208
Recruitment Status : Completed
First Posted : September 20, 2017
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Brief Summary:
To assess the pharmacokinetics of MCI-186 after a single intravenous infusion of 30mg/hour in subjects with mild or moderate renal impairment compared to subjects with normal renal function.

Condition or disease Intervention/treatment Phase
Renal Impairment Healthy Drug: MCI-186 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MCI-186 in Subjects With Mild or Moderate Renal Impairment Compared to Subjects With Normal Renal Function
Actual Study Start Date : October 27, 2016
Actual Primary Completion Date : April 16, 2018
Actual Study Completion Date : April 20, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Edaravone

Arm Intervention/treatment
Experimental: mild renal impairment Drug: MCI-186
30 mg of edaravone will be administered intravenously over 60 minutes.
Other Names:
  • Edaravone
  • Radicut

Experimental: moderated renal impairment Drug: MCI-186
30 mg of edaravone will be administered intravenously over 60 minutes.
Other Names:
  • Edaravone
  • Radicut

Experimental: normal renal function Drug: MCI-186
30 mg of edaravone will be administered intravenously over 60 minutes.
Other Names:
  • Edaravone
  • Radicut




Primary Outcome Measures :
  1. Cmax [ Time Frame: pre-dose to 48 hours post-dose ]
  2. AUC0-last [ Time Frame: pre-dose to 48 hours post-dose ]
  3. AUC0-∞ [ Time Frame: pre-dose to 48 hours post-dose ]

Secondary Outcome Measures :
  1. t½ [ Time Frame: pre-dose to 48 hours post-dose ]


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

All subjects

  • Able to provide written informed consent to participate in this study after reading the ICF
  • Subjects is able to understand and willing to cooperate and comply with the Protocol restrictions and requirements
  • A body weight of ≥45 kg in males or ≥40 kg in females and a body mass index ranging from 18 to 30 kg/m2

Renal impaired subjects (in addition)

  • Subjects with mild renal impairment defined as eGFR 60-89 mL/min/1.73m2 and subjects with moderate renal impairment defined as eGFR 30-59 mL/min/1.73m2
  • Chronic and stable renal impairment

Healthy subjects (in addition)

  • Subject with normal renal function defined as eGFR≥90 mL/min/1.73m2
  • Good health and free from clinically significant illness or disease

Exclusion Criteria:

All subjects

  • Presence or history of severe allergy to food, or any medicinal product or relevant excipient that is of clinical significance
  • Subjects were previously administered MCI-186
  • Positive urine drug screen (if not due to concomitant medication) or alcohol test
  • History of alcohol abuse or drug abuse
  • Presence of active infection requiring antibiotics
  • Positive test for human immunodeficiency virus (HIV) antigen/antibody, hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (HCVAb)

Renal impairment subject (in addition)

  • Acute renal failure
  • History of renal transplantation
  • Aspartate aminotransferase (AST) activity, or an alanine aminotransferase (ALT) activity of at least 3 times the upper limit of normal (ULN) range
  • Uncontrolled, or untreated hypertension defined as systolic blood pressure (SBP)>180 mmHg and/or diastolic blood pressure (DBP)>110 mmHg
  • Start of any new medication or new any changes to a current dosage

Healthy subject (in addition)

  • History or presence of any renal disease
  • Uncontrolled, or untreated hypertension defined as systolic blood pressure (SBP)>160 mmHg and/or diastolic blood pressure (DBP)>100 mmHg

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03289208


Locations
Japan
Investigational site
Tokyo, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
Study Director: General Manager Mitsubishi Tanabe Pharma Corporation

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT03289208     History of Changes
Other Study ID Numbers: MCI-186-J22
First Posted: September 20, 2017    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Phenylmethylpyrazolone
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs