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

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