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

December 2, 2013 updated by: Ono Pharma USA Inc

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92803
        • Anaheim Clinical Site
    • Florida
      • Orlando, Florida, United States, 32803
        • Orlando Clinical Site
      • South Miami, Florida, United States, 33034
        • South Miami Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: ONO-2745 /CNS 7056
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
Drug: ONO-2745 /CNS 7056
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
Drug: ONO-2745 /CNS 7056
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
Drug: ONO-2745 /CNS 7056
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
Drug: ONO-2745 /CNS 7056

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Overall safety: Pre-dose to 7 days post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ono Pharma USA Inc

Collaborators

Ono Pharmaceutical Co. Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

February 11, 2013

First Submitted That Met QC Criteria

February 12, 2013

First Posted (ESTIMATE)

February 13, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

December 3, 2013

Last Update Submitted That Met QC Criteria

December 2, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONO-2745IVU007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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