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

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

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

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.

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