Phase I Study of OPC-61815
Primary Purpose
Congestive Heart Failure
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
OPC-61815 16mg
OPC-61815 32mg
Moxifloxacin
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Congestive Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Body mass index (BMI) [body weight in kg / (height in m)2] of at least 18.5 kg/m2 and less than 25.0 kg/m2 as a result of at the screening examination
- Judged by the investigator or subinvestigator to be capable of providing written informed consent prior to start of any trial-related procedures and capable of complying with the procedures for this trial
Exclusion Criteria:
- Subjects with a medical history of convulsive disorder, long QT syndrome (including family history), syncope during swimming, or any other type of syncope or cryptogenic loss of consciousness
- Subjects with a serum electrolyte abnormality (hypokalemia, hypomagnesemia, hypocalcemia, etc)
- Subjects with a family history of sudden death
Sites / Locations
- Kyusyu Region
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
OPC-61815 16mg
OPC-61815 32mg
Moxifloxacin
Placebo
Arm Description
OPC-61815 16mg will be intravenously administered once a week.
OPC-61815 32mg will be intravenously administered once a week.
400mg tablet will be administrated once a week.
Placebo will be intravenously administered once a week.
Outcomes
Primary Outcome Measures
Time-matched Difference Between the OPC-61815/Moxifloxacin and Placebo Data in Change From Baseline for QTcF in 12-lead Holter Electrocardiogram (ECG)
For each OPC-61815 dose, the upper limit of the confidence interval (CI) for the time-matched difference in the least squares (LS) mean for the change in QT corrected for heart rate by Fridericia's formula (QTcF) from baseline compared to the placebo data was evaluated to determine if it was lower than 10 msec at all postdose time points. Using a linear mixed effect model with baseline QTcF in each treatment period as a covariate, treatment, sequence, treatment period, time point, and interaction between treatment and time point as fixed effects, and subject as a random effect, point estimates and CIs for the time-matched difference in the LS mean for the change in QTcF from baseline compared to the placebo data were calculated.
Secondary Outcome Measures
Full Information
NCT ID
NCT03510663
First Posted
April 18, 2018
Last Updated
April 13, 2021
Sponsor
Otsuka Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03510663
Brief Title
Phase I Study of OPC-61815
Official Title
A Single-center, Randomized, Double-blind (for OPC-61815 and Placebo), Placebo- and Moxifloxacin Positive-controlled, 4-Period Crossover Trial to Evaluate the Effect of Single Intravenous Administration of OPC-61815 at 16 and 32 mg on QT/QTc Interval in Healthy Male Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
May 8, 2018 (Actual)
Primary Completion Date
July 5, 2018 (Actual)
Study Completion Date
July 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To investigate the effects of intravenous administration of OPC-61815 at 16 and 32 mg on QT/QTc interval in healthy male subjects
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OPC-61815 16mg
Arm Type
Experimental
Arm Description
OPC-61815 16mg will be intravenously administered once a week.
Arm Title
OPC-61815 32mg
Arm Type
Experimental
Arm Description
OPC-61815 32mg will be intravenously administered once a week.
Arm Title
Moxifloxacin
Arm Type
Active Comparator
Arm Description
400mg tablet will be administrated once a week.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be intravenously administered once a week.
Intervention Type
Drug
Intervention Name(s)
OPC-61815 16mg
Intervention Description
OPC-61815 16mg will be intravenously administered once a week.
Intervention Type
Drug
Intervention Name(s)
OPC-61815 32mg
Intervention Description
OPC-61815 32mg will be intravenously administered once a week.
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin
Intervention Description
400mg tablet will be administrated once a week.
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Placebo will be intravenously administered once a week.
Primary Outcome Measure Information:
Title
Time-matched Difference Between the OPC-61815/Moxifloxacin and Placebo Data in Change From Baseline for QTcF in 12-lead Holter Electrocardiogram (ECG)
Description
For each OPC-61815 dose, the upper limit of the confidence interval (CI) for the time-matched difference in the least squares (LS) mean for the change in QT corrected for heart rate by Fridericia's formula (QTcF) from baseline compared to the placebo data was evaluated to determine if it was lower than 10 msec at all postdose time points. Using a linear mixed effect model with baseline QTcF in each treatment period as a covariate, treatment, sequence, treatment period, time point, and interaction between treatment and time point as fixed effects, and subject as a random effect, point estimates and CIs for the time-matched difference in the LS mean for the change in QTcF from baseline compared to the placebo data were calculated.
Time Frame
Baseline, 1h, 1.5h, 2h, 3h, 4h, 6h, 12h, 24h after dosing
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Body mass index (BMI) [body weight in kg / (height in m)2] of at least 18.5 kg/m2 and less than 25.0 kg/m2 as a result of at the screening examination
Judged by the investigator or subinvestigator to be capable of providing written informed consent prior to start of any trial-related procedures and capable of complying with the procedures for this trial
Exclusion Criteria:
Subjects with a medical history of convulsive disorder, long QT syndrome (including family history), syncope during swimming, or any other type of syncope or cryptogenic loss of consciousness
Subjects with a serum electrolyte abnormality (hypokalemia, hypomagnesemia, hypocalcemia, etc)
Subjects with a family history of sudden death
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osamu Sato
Organizational Affiliation
Otsuka Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Kyusyu Region
City
Fukuoka
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Phase I Study of OPC-61815
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