Status:
COMPLETED
Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Renal Impairment
Lead Sponsor:
Tanabe Pharma Corporation
Conditions:
Renal Impairment
Healthy
Eligibility:
All Genders
20-75 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 27 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2018
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03289208
Start Date
October 27 2016
End Date
April 20 2018
Last Update
January 8 2026
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Investigational site
Tokyo, Japan