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ONO-2745/CNS 7056

Phase 1

Hepatic Impairment | Small molecule | Gastrointestinal |BrainsWay Ltd.|Last Updated: Dec 3, 2013

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

ONO-2745/CNS 7056 · 1 trial · 2 indications

Phase 1 1
NCT01790607An Open-label, Single-dose, Intravenous Administration Study of ONO-2745/CNS 7056 in Subjects With Chronic Hepatic ImpairmentHepatic Impairment
COMPLETED20 Analytics
PHASE1COMPLETED
An Open-label, Single-dose, Intravenous Administration Study of ONO-2745/CNS 7056 in Subjects With Chronic Hepatic Impairment
Hepatic ImpairmentUnlock trial analytics

Study Endpoints

Primary Endpoints

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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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Subjects with moderate chronic hepatic impairmentEXPERIMENTALSingle IV bolus of ONO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight
Healthy subjects matched to moderate hepatic impaired subjectsEXPERIMENTALSingle IV bolus of ONO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight
Subjects with mild chronic hepatic impairmentEXPERIMENTALSingle IV bolus of ONO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight
Healthy subjects matched to mild hepatic impaired subjectsEXPERIMENTALSingle IV bolus of NO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight
Subjects with severe chronic hepatic impairmentEXPERIMENTALSingle IV bolus of ONO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight

Interventions

NameTypeDescription
ONO-2745 /CNS 7056DRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites3

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 b...

Countries:United States
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Frequently asked questions about ONO-2745/CNS 7056

What is ONO-2745/CNS 7056 used for?

ONO-2745/CNS 7056 is an investigational small molecule being studied for use in hepatic impairment. It is being developed by BrainsWay Ltd. (BWAY). The drug is in Phase 1 clinical development and has not been approved by regulatory authorities.

What does ONO-2745/CNS 7056 target?

The molecular target of ONO-2745/CNS 7056 has not been disclosed. It is a small molecule being investigated for hepatic impairment, but its specific mechanism of action is not publicly available from the clinical trial data.

Who makes ONO-2745/CNS 7056?

ONO-2745/CNS 7056 is being developed by BrainsWay Ltd., a company traded under the ticker BWAY. The drug is currently in Phase 1 clinical development for hepatic impairment.

What phase is ONO-2745/CNS 7056 in?

ONO-2745/CNS 7056 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. One Phase 1 trial has been completed.

What clinical trials is ONO-2745/CNS 7056 in?

ONO-2745/CNS 7056 has one completed clinical trial, NCT01790607, titled "An Open-label, Single-dose, Intravenous Administration Study of ONO-2745/CNS 7056 in Subjects With Chronic Hepatic Impairment." The study enrolled 20 participants in the United States and included healthy volunteers.

Is ONO-2745/CNS 7056 the same as CNS 7056?

Yes, ONO-2745/CNS 7056 is also known as CNS 7056. The drug is being developed by BrainsWay Ltd. and is currently in Phase 1 clinical trials for hepatic impairment.