Clinical trial NCT03289234: Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Hepatic Impairment
Official title: A Multi-Center, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MCI-186 in Subjects With Mild or Moderate Hepatic Impairment Compared to Subjects With Normal Hepatic Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Impairment
Healthy
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2017-09-20
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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


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

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

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)

Primary outcomes:
measure: Cmax
timeFrame: pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose
measure: AUC0-last
timeFrame: pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose
measure: AUC0-∞
timeFrame: pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose
Secondary outcomes:
measure: t½
timeFrame: pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Investigational site
city: Tokyo
country: Japan
facility: Investigational site
Study officials:
affiliation: Mitsubishi Tanabe Pharma Corporation
name: General Manager
role: STUDY_DIRECTOR
References:
citation: Nakamaru Y, Kakubari M, Yoshida K, Akimoto M, Todorovic V, Greis T, Kondo K. Open-label, Single-dose Studies of the Pharmacokinetics of Edaravone in Subjects with Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects with Normal Hepatic Functioning. Clin Ther. 2020 Aug;42(8):1467-1482.e4. doi: 10.1016/j.clinthera.2020.06.016. Epub 2020 Aug 14.