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Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Renal Impairment
Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Renal Impairment
CompletedPhase 1
Sponsor: Shionogi
Conditions: Renal Impairment, Healthy
Interventions: MCI-186
Countries: Japan
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 overview
Sex: ALL
Age: 20 Years to 75 Years
Healthy volunteers: Yes
Study type: INTERVENTIONAL
Eligibility 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
Locations (1)
- Tokyo, Japan