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OpenTrials
Completed

NCT Number: NCT01790607

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

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

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Key information

Conditions

Hepatic Impairment Behavior Coitus Healthy Sexual Behavior

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim Clinical Site, Anaheim, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ONO-2745 /CNS 7056

Drug

Primary outcomes

  1. To study the effect of hepatic impairment on the pharmacokinetics of ONO-2745/CNS 7045 by assessment of drug concentration through blood sample analysis

    Time frame: PK: Pre-dose to 4 hours post-dose

  2. 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

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

Sponsors and collaborators

Lead sponsor

Ono Pharma USA Inc

Industry

Collaborators

  • Ono Pharmaceutical Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
First posted
Feb 13, 2013
Registry last updated
Dec 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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