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

NCT ID: NCT01790607

Last Updated: 2013-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Brief Summary

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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

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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.

Conditions

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Hepatic Impairment Healthy

Keywords

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Adult healthy subjects will be matched with individual subjects by age (± 5 years, gender, and BMI (± 15%)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Subjects with moderate chronic hepatic impairment

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

Group Type EXPERIMENTAL

ONO-2745 /CNS 7056

Intervention Type DRUG

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

Group Type EXPERIMENTAL

ONO-2745 /CNS 7056

Intervention Type DRUG

Subjects with mild chronic hepatic impairment

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

Group Type EXPERIMENTAL

ONO-2745 /CNS 7056

Intervention Type DRUG

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

Group Type EXPERIMENTAL

ONO-2745 /CNS 7056

Intervention Type DRUG

Subjects with severe chronic hepatic impairment

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

Group Type EXPERIMENTAL

ONO-2745 /CNS 7056

Intervention Type DRUG

Interventions

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ONO-2745 /CNS 7056

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ono Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role collaborator

Ono Pharma USA Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ono Pharma USA, Inc.

Role: STUDY_DIRECTOR

Ono Pharmaceutical Co. Ltd

Locations

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Anaheim Clinical Site

Anaheim, California, United States

Site Status

Orlando Clinical Site

Orlando, Florida, United States

Site Status

South Miami Clinical Site

South Miami, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34246461 (View on PubMed)

Other Identifiers

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ONO-2745IVU007

Identifier Type: -

Identifier Source: org_study_id