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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

NCT03289208

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