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

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Ono Pharmaceuticals

Status and phase

Completed
Phase 1

Conditions

Hepatic Impairment
Healthy

Treatments

Drug: ONO-2745 /CNS 7056

Study type

Interventional

Funder types

Industry

Identifiers

NCT01790607
ONO-2745IVU007

Details and patient eligibility

About

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

Full 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.

Enrollment

20 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 5 patient groups

Subjects with moderate chronic hepatic impairment
Experimental group
Description:
Single IV bolus of ONO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight
Treatment:
Drug: ONO-2745 /CNS 7056
Healthy subjects matched to moderate hepatic impaired subjects
Experimental group
Description:
Single IV bolus of ONO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight
Treatment:
Drug: ONO-2745 /CNS 7056
Subjects with mild chronic hepatic impairment
Experimental group
Description:
Single IV bolus of ONO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight
Treatment:
Drug: ONO-2745 /CNS 7056
Healthy subjects matched to mild hepatic impaired subjects
Experimental group
Description:
Single IV bolus of NO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight
Treatment:
Drug: ONO-2745 /CNS 7056
Subjects with severe chronic hepatic impairment
Experimental group
Description:
Single IV bolus of ONO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight
Treatment:
Drug: ONO-2745 /CNS 7056

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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