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

Phase 1

Completed

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

• Registration Number: NCT03289234
• 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 Hepatic impairment compared to subjects with normal hepatic function

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-16
• Study First Submitted: 2017-09-19
• Study First Submitted QC: 2017-09-19
• Study First Posted: 2017-09-20
• Primary Completion: 2018-07-20
• Study Completion: 2018-07-24
• 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: 22

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

Hepatic impaired subjects (in addition)

• A Child-Pugh score of 5 or 6 for subjects with mild hepatic impairment, and between 7 and 9, inclusive, for subjects with moderate hepatic impairment
• Chronic and stable hepatic impairment

Healthy subjects (in addition)

• Subject with normal hepatic function
• 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 drug abuse
• Presence of alcohol abuse
• Presence of active infection requiring antibiotics
• Positive test for human immunodeficiency virus (HIV) antigen/antibody
• Uncontrolled, or untreated hypertension defined as systolic blood pressure (SBP)>160 mmHg and/or diastolic blood pressure (DBP)>100 mmHg
• eGFR <60 mL/min/1.73m2

Hepatic impairment subject (in addition)

• Subjects with severe ascites

Healthy subject (in addition)

• History or presence of any parenchymal hepatic disease
• Positive test for hepatitis B surface antigen (HBsAg) and hepatitis C virus antibody (HCVAb)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mild hepatic impairment	MCI-186	-
moderate hepatic impairment	MCI-186	-
normal hepatic function	MCI-186	-

Primary Outcome Measures

Name	Time	Method
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
AUC0-last	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