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

Tanabe Pharma Corporation

Status and phase: Completed; Phase 1

Conditions: Healthy; Renal Impairment

Treatments: Drug: MCI-186

Study type: Interventional

Funder types: Industry

Identifiers

NCT03289208

MCI-186-J22

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

mild renal impairment

Experimental group

Treatment:

Drug: MCI-186

moderated renal impairment

Experimental group

Treatment:

Drug: MCI-186

normal renal function

Experimental group

Treatment:

Drug: MCI-186