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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01790607
• Other study ID #: ONO-2745IVU007
• Status: Completed
• Phase: Phase 1
• First received: February 11, 2013
• Last updated: December 2, 2013
• Start date: February 2013

Study information

• Verified date: December 2013
• Source: Ono Pharmaceutical Co. Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy
• Hepatic Impairment
• Liver Diseases

Intervention

Drug:
• ONO-2745 /CNS 7056

Locations

Country	Name	City	State
United States	Anaheim Clinical Site	Anaheim	California
United States	Orlando Clinical Site	Orlando	Florida
United States	South Miami Clinical Site	South Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Ono Pharma USA Inc	Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes