NCT01790607

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 13, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Last Updated

December 3, 2013

Status Verified

December 1, 2013

Enrollment Period

9 months

First QC Date

February 11, 2013

Last Update Submit

December 2, 2013

Conditions

Hepatic ImpairmentHealthy

Keywords

Adult healthy subjects will be matched with individual subjects by age (± 5 years, gender, and BMI (± 15%)

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (5)

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

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

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

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

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

Drug: ONO-2745 /CNS 7056

Interventions

ONO-2745 /CNS 7056DRUG
Healthy subjects matched to mild hepatic impaired subjectsHealthy subjects matched to moderate hepatic impaired subjectsSubjects with mild chronic hepatic impairmentSubjects with moderate chronic hepatic impairmentSubjects with severe chronic hepatic impairment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Anaheim Clinical Site

Anaheim, California, 92803, United States

Location

Orlando Clinical Site

Orlando, Florida, 32803, United States

Location

South Miami Clinical Site

South Miami, Florida, 33034, United States

Location

Related Publications (1)

  • 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.

    PMID: 34246461DERIVED

MeSH Terms

Conditions

Coitus

Interventions

remimazolam

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Study Officials

  • Ono Pharma USA, Inc.

    Ono Pharmaceutical Co. Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2013

First Posted

February 13, 2013

Study Start

February 1, 2013

Primary Completion

November 1, 2013

Last Updated

December 3, 2013

Record last verified: 2013-12

Locations

US(3)