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

Phase 1

Completed

• Conditions: Renal Impairment; Healthy
• Interventions: Drug: MCI-186

• Registration Number: NCT03289208
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-27
• Study First Submitted: 2017-09-19
• Study First Submitted QC: 2017-09-19
• Study First Posted: 2017-09-20
• Primary Completion: 2018-04-16
• Study Completion: 2018-04-20
• Results First Submitted: 2020-02-13
• Results First Submitted QC: 2020-02-13
• Results First Posted: 2020-02-28
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-03
• Last Update Posted: 2023-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mild renal impairment	MCI-186	-
moderated renal impairment	MCI-186	-
normal renal function	MCI-186	-

Primary Outcome Measures

Name	Time	Method
AUC0-last	pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose
Cmax	pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose
AUC0-∞	pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose

Secondary Outcome Measures

Name	Time	Method
t½	pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose

Trial Locations

Locations (1)

Investigational site; 🇯🇵 Tokyo, Japan