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

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: Healthy; Hepatic Impairment
• Intervention / Treatment: Drug: ONO-2745 /CNS 7056

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

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

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

How is the study designed?

Design Details

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

Number of Arms

5

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	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	Overall safety: Pre-dose to 7 days post-dose

Collaborators and Investigators

• Sponsor: Ono Pharma USA Inc
• Collaborators: Ono Pharmaceutical Co. Ltd

Publications and helpful links

General Publications

• 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.

Study record dates

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: Adult healthy subjects will be matched with individual subjects by age (± 5 years, gender, and BMI (± 15%)
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: ONO-2745IVU007