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

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)

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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