An Open-label, Single-dose, Intravenous Administration Study of ONO-2745/CNS 7056 in Subjects With Chronic Hepatic Impairment
Study Details
Study Description
Brief Summary
To evaluate and compare the pharmacokinetics and safety of ONO-2745/CNS 7056 in subjects with the hepatic impairment and matched healthy subjects.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Subjects with moderate chronic hepatic impairment Single IV bolus of ONO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight |
Drug: ONO-2745 /CNS 7056
|
| Experimental: 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 |
Drug: ONO-2745 /CNS 7056
|
| Experimental: Subjects with mild chronic hepatic impairment Single IV bolus of ONO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight |
Drug: ONO-2745 /CNS 7056
|
| Experimental: 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 |
Drug: ONO-2745 /CNS 7056
|
| Experimental: Subjects with severe chronic hepatic impairment Single IV bolus of ONO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight |
Drug: ONO-2745 /CNS 7056
|
Outcome Measures
Primary Outcome Measures
- To study the effect of hepatic impairment on the pharmacokinetics of ONO-2745/CNS 7045 by assessment of drug concentration through blood sample analysis [PK: Pre-dose to 4 hours post-dose]
- 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 [Overall safety: Pre-dose to 7 days post-dose]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Anaheim Clinical Site | Anaheim | California | United States | 92803 |
| 2 | Orlando Clinical Site | Orlando | Florida | United States | 32803 |
| 3 | South Miami Clinical Site | South Miami | Florida | United States | 33034 |
Sponsors and Collaborators
- Ono Pharma USA Inc
- Ono Pharmaceutical Co. Ltd
Investigators
- Study Director: Ono Pharma USA, Inc., Ono Pharmaceutical Co. Ltd
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ONO-2745IVU007