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

Primary Purpose

Hepatic Impairment, Healthy

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ONO-2745 /CNS 7056
Sponsored by
Ono Pharma USA Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Impairment focused on measuring Adult healthy subjects will be matched with individual subjects by age (± 5 years, gender, and BMI (± 15%)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Anaheim Clinical Site
  • Orlando Clinical Site
  • South Miami Clinical Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Subjects with moderate chronic hepatic impairment

Healthy subjects matched to moderate hepatic impaired subjects

Subjects with mild chronic hepatic impairment

Healthy subjects matched to mild hepatic impaired subjects

Subjects with severe chronic hepatic impairment

Arm Description

Single IV bolus of ONO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight

Single IV bolus of ONO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight

Single IV bolus of ONO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight

Single IV bolus of NO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight

Single IV bolus of ONO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight

Outcomes

Primary Outcome 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
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

Secondary Outcome Measures

Full Information

First Posted
February 11, 2013
Last Updated
December 2, 2013
Sponsor
Ono Pharma USA Inc
Collaborators
Ono Pharmaceutical Co. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01790607
Brief Title
An Open-label, Single-dose, Intravenous Administration Study of ONO-2745/CNS 7056 in Subjects With Chronic Hepatic Impairment
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ono Pharma USA Inc
Collaborators
Ono Pharmaceutical Co. Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Impairment, Healthy
Keywords
Adult healthy subjects will be matched with individual subjects by age (± 5 years, gender, and BMI (± 15%)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subjects with moderate chronic hepatic impairment
Arm Type
Experimental
Arm Description
Single IV bolus of ONO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight
Arm Title
Healthy subjects matched to moderate hepatic impaired subjects
Arm Type
Experimental
Arm Description
Single IV bolus of ONO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight
Arm Title
Subjects with mild chronic hepatic impairment
Arm Type
Experimental
Arm Description
Single IV bolus of ONO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight
Arm Title
Healthy subjects matched to mild hepatic impaired subjects
Arm Type
Experimental
Arm Description
Single IV bolus of NO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight
Arm Title
Subjects with severe chronic hepatic impairment
Arm Type
Experimental
Arm Description
Single IV bolus of ONO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight
Intervention Type
Drug
Intervention Name(s)
ONO-2745 /CNS 7056
Primary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ono Pharma USA, Inc.
Organizational Affiliation
Ono Pharmaceutical Co. Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Anaheim Clinical Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92803
Country
United States
Facility Name
Orlando Clinical Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
South Miami Clinical Site
City
South Miami
State/Province
Florida
ZIP/Postal Code
33034
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34246461
Citation
Stohr T, Colin PJ, Ossig J, Pesic M, Borkett K, Winkle P, Struys MMRF, Schippers F. Pharmacokinetic properties of remimazolam in subjects with hepatic or renal impairment. Br J Anaesth. 2021 Sep;127(3):415-423. doi: 10.1016/j.bja.2021.05.027. Epub 2021 Jul 8.
Results Reference
derived

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

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