An Open-label, Single-dose, Intravenous Administration Study of ONO-2745/CNS 7056 in Subjects With Chronic Hepatic Impairment

Study Overview
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Brief Summary
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To evaluate and compare the pharmacokinetics and safety of ONO-2745/CNS 7056 in subjects with the hepatic impairment and matched healthy subjects.

Detailed Description
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In Part One, 8 subjects with moderate hepatic impairment (Child Pugh Scale B) and 8 matched healthy subjects will be enrolled. In Part 2, 8 subjects with mild hepatic impairment (Child-Pugh Scale A) and 8 matched healthy subjects will be enrolled. In Part 3, 3 subjects with severe hepatic impairment (Child-Pugh Scale C) will be enrolled. Parts 2 and 3 will only be initiated if the criteria per protocol is met in Part One. The pharmacokinetics and safety profiles will be compared between hepatic impaired subjects and healthy subjects.

Official Title
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An Open-label, Single-dose,Intravenous Administration Study to Compare the Pharmacokinetics and Safety of ONO-2745/CNS 7056 in Subjects With Chronic Hepatic Impairment With Matching Healthy Subjects

Conditions
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Hepatic Impairment, Healthy

Intervention / Treatment
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* Drug: ONO-2745 /CNS 7056


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females between 18 and 65 years of age Negative test for the selected drugs of abuse at screening Hepatic impaired subjects: Stable hepatic function and medication regimen for at least 28 days prior to check-in Degree of hepatic impairment will be determined by the Child-Pugh Scale Exclusion Criteria: Clinical manifestation of any disease (except hepatic impaired subjects) History of significant hypersensitivity, intolerance, or allergy to any drug compound, including food, or other substance

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects with moderate chronic hepatic impairment<br>Single IV bolus of ONO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight | Drug: ONO-2745 /CNS 7056<br> <br> |
| Experimental: Healthy subjects matched to moderate hepatic impaired subjects<br>Single IV bolus of ONO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight | Drug: ONO-2745 /CNS 7056<br> <br> |
| Experimental: Subjects with mild chronic hepatic impairment<br>Single IV bolus of ONO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight | Drug: ONO-2745 /CNS 7056<br> <br> |
| Experimental: Healthy subjects matched to mild hepatic impaired subjects<br>Single IV bolus of NO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight | Drug: ONO-2745 /CNS 7056<br> <br> |
| Experimental: Subjects with severe chronic hepatic impairment<br>Single IV bolus of ONO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight | Drug: ONO-2745 /CNS 7056<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study the effect of hepatic impairment on the pharmacokinetics of ONO-2745/CNS 7045 by assessment of drug concentration through blood sample analysis |  | PK: Pre-dose to 4 hours post-dose | 
| To study the effect of ONO-2745/CNS 7045 on the subjects with hepatic impairment by evaluating the safety parameters per protocol including labs, vitals and adverse events |  | Overall safety: Pre-dose to 7 days post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adult healthy subjects will be matched with individual subjects by age (± 5 years, gender, and BMI (± 15%)