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| Name | Class |
|---|---|
| Ono Pharmaceutical Co., Ltd. | INDUSTRY |
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To evaluate and compare the pharmacokinetics and safety of ONO-2745/CNS 7056 in subjects with the hepatic impairment and matched healthy subjects.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with moderate chronic hepatic impairment | Experimental | Single IV bolus of ONO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight |
|
| Healthy subjects matched to moderate hepatic impaired subjects | Experimental | Single IV bolus of ONO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight |
|
| Subjects with mild chronic hepatic impairment | Experimental | Single IV bolus of ONO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight |
|
| Healthy subjects matched to mild hepatic impaired subjects | Experimental | Single IV bolus of NO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight |
|
| Subjects with severe chronic hepatic impairment | Experimental | Single IV bolus of ONO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONO-2745 /CNS 7056 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Hepatic impaired subjects:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ono Pharma USA, Inc. | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Site | Anaheim | California | 92803 | United States | ||
| Orlando Clinical Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34246461 | Derived | Stohr T, Colin PJ, Ossig J, Pesic M, Borkett K, Winkle P, Struys MMRF, Schippers F. Pharmacokinetic properties of remimazolam in subjects with hepatic or renal impairment. Br J Anaesth. 2021 Sep;127(3):415-423. doi: 10.1016/j.bja.2021.05.027. Epub 2021 Jul 8. |
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| ID | Term |
|---|---|
| D003075 | Coitus |
| ID | Term |
|---|---|
| D012725 | Sexual Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C522201 | remimazolam |
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| Orlando |
| Florida |
| 32803 |
| United States |
| South Miami Clinical Site | South Miami | Florida | 33034 | United States |