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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2013

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.

Interventions

  • Drug: ONO-2745 /CNS 7056

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • To study the effect of hepatic impairment on the pharmacokinetics of ONO-2745/CNS 7045 by assessment of drug concentration through blood sample analysis
    • Time Frame: PK: Pre-dose to 4 hours post-dose
  • 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
    • Time Frame: Overall safety: Pre-dose to 7 days post-dose

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Ono Pharma USA Inc
  • Collaborator
    • Ono Pharmaceutical Co. Ltd
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ono Pharma USA, Inc., Study Director, Ono Pharmaceutical Co. Ltd

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.