NCT01790607

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Ono Pharma USA Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Hepatic Impairment
• Healthy

Interventions

Type	Name	Description
DRUG	ONO-2745 /CNS 7056

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-11-01
• First posted: 2013-02-13
• Last updated: 2013-12-03

Locations

3 sites across 1 country: United States