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



Status:Recruiting
Conditions:Healthy Studies, Gastrointestinal
Therapuetic Areas:Gastroenterology, Other
Healthy:No
Age Range:18 - 65
Updated:10/19/2013
Start Date:February 2013
Contact:Brenda Souza
Phone:(609) 512-4129

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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


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
We found this trial at
3
sites
Anaheim, California 92803
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Orlando, Florida 32803
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South Miami, Florida 33034
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South Miami, FL
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