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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ono Pharma USA Inc
• Collaborator: Ono Pharmaceutical Co. Ltd

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