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

Phase 1

Completed

• Conditions: Healthy; Hepatic Impairment
• Interventions: Drug: ONO-2745 /CNS 7056

• Registration Number: NCT01790607
• Lead Sponsor: Ono Pharma USA Inc

Brief 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.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-11
• Study First Submitted QC: 2013-02-12
• Study First Posted: 2013-02-13
• Primary Completion: 2013-11
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-02
• Last Update Posted: 2013-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects with moderate chronic hepatic impairment	ONO-2745 /CNS 7056	Single IV bolus of ONO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight
Subjects with mild chronic hepatic impairment	ONO-2745 /CNS 7056	Single IV bolus of ONO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight
Healthy subjects matched to mild hepatic impaired subjects	ONO-2745 /CNS 7056	Single IV bolus of NO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight
Subjects with severe chronic hepatic impairment	ONO-2745 /CNS 7056	Single IV bolus of ONO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight
Healthy subjects matched to moderate hepatic impaired subjects	ONO-2745 /CNS 7056	Single IV bolus of ONO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (3)

South Miami Clinical Site; 🇺🇸 South Miami, Florida, United States

Anaheim Clinical Site; 🇺🇸 Anaheim, California, United States

Orlando Clinical Site; 🇺🇸 Orlando, Florida, United States