Hepatic ImpairmentPhase 1NCT01790607
An Open-label, Single-dose, Intravenous Administration Study of ONO-2745/CNS 7056 in Subjects With Chronic Hepatic Impairment
A Phase 1 study testing ONO-2745 /CNS 7056 in people with Hepatic Impairment and Healthy, run by Ono Pharma USA Inc at 3 sites in United States.
Trial summary
To evaluate and compare the pharmacokinetics and safety of ONO-2745/CNS 7056 in subjects with the hepatic impairment and matched healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment, Healthy
- What is being tested?
- ONO-2745 /CNS 7056
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2013to Nov 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Anaheim Clinical Site
Anaheim, California, 92803
Orlando Clinical Site
Orlando, Florida, 32803
South Miami Clinical Site
South Miami, Florida, 33034
About this study
Official 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
To evaluate and compare the pharmacokinetics and safety of ONO-2745/CNS 7056 in subjects with the hepatic impairment and matched healthy subjects.
Read the 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.
- Conditions
- Hepatic Impairment, Healthy
- Being tested
- ONO-2745 /CNS 7056
- Keywords
- Adult healthy subjects will be matched with individual subjects by age (± 5 years, gender, and BMI (± 15%)
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-2745 /CNS 7056Drug
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: ONO-2745 /CNS 7056 |
| 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 Receives: Drug: ONO-2745 /CNS 7056 |
| 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 Receives: Drug: ONO-2745 /CNS 7056 |
| 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 Receives: Drug: ONO-2745 /CNS 7056 |
| 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 Receives: Drug: ONO-2745 /CNS 7056 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the effect of hepatic impairment on the pharmacokinetics of ONO-2745/CNS 7045 by assessment of drug concentration through blood sample analysis
Measured: 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
Measured: Overall safety: Pre-dose to 7 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharma USA Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Ono Pharma USA, Inc., Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790607
- Sponsor's protocol ID
- ONO-2745IVU007
- Status last verified
- Dec 2013
- First submitted
- 11 Feb 2013
- Last updated
- 3 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34246461
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01790607
- Acronym / sponsor ID
- ONO-2745IVU007
- Conditions
- Hepatic Impairment, Healthy
- Keywords
- Adult healthy subjects will be matched with individual subjects by age (± 5 years, gender, and BMI (± 15%)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ono Pharma USA IncIndustry (pharma, biotech, devices)
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Study start
- Feb 2013
- Primary completion
- Nov 2013 (actual)
- First posted
- 13 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate and compare the pharmacokinetics and safety of ONO-2745/CNS 7056 in subjects with the hepatic impairment and matched healthy subjects.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Subjects with moderate chronic hepatic impairment | Experimental | Drug: ONO-2745 /CNS 7056Single 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 | Drug: ONO-2745 /CNS 7056Single IV bolus of ONO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight |
| Subjects with mild chronic hepatic impairment | Experimental | Drug: ONO-2745 /CNS 7056Single 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 | Drug: ONO-2745 /CNS 7056Single IV bolus of NO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight |
| Subjects with severe chronic hepatic impairment | Experimental | Drug: ONO-2745 /CNS 7056Single IV bolus of ONO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females between 18 and 65 years of age
- Negative test for the selected drugs of abuse at screening
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONO-2745 /CNS 7056 | Drug | Healthy subjects matched to mild hepatic impaired subjects, Healthy subjects matched to moderate hepatic impaired subjects, Subjects with mild chronic hepatic impairment, Subjects with moderate chronic hepatic impairment, Subjects with severe chronic hepatic impairment |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2013.
- Derived from this study: PubMed 34246461Stohr 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ono Pharma USA, Inc. study director
Ono Pharmaceutical Co., Ltd.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ONO-2745 /CNS 7056 in people with Hepatic Impairment and Healthy, run by Ono Pharma USA Inc at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01790607, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2013.