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

Completed · Phase 1

Conditions studied: Hepatic Impairment, Healthy

In brief

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

Key facts

Study ID

NCT01790607

Run by

Ono Pharma USA Inc

People needed

20

Starts

2013-02-01

Last updated by the study team

2013-12-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Anaheim Clinical Site — Anaheim, California, United States
• Orlando Clinical Site — Orlando, Florida, United States
• South Miami Clinical Site — South Miami, Florida, United States

Full record on ClinicalTrials.gov

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