Phase I Study of OPC-61815

Study Overview
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Brief Summary
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To investigate the effects of intravenous administration of OPC-61815 at 16 and 32 mg on QT/QTc interval in healthy male subjects

Official Title
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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

Conditions
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Congestive Heart Failure

Intervention / Treatment
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* Drug: OPC-61815 16mg
* Drug: OPC-61815 32mg
* Drug: Moxifloxacin
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OPC-61815 16mg<br>OPC-61815 16mg will be intravenously administered once a week. | Drug: OPC-61815 16mg<br>* OPC-61815 16mg will be intravenously administered once a week.<br>|
| Experimental: OPC-61815 32mg<br>OPC-61815 32mg will be intravenously administered once a week. | Drug: OPC-61815 32mg<br>* OPC-61815 32mg will be intravenously administered once a week.<br>|
| Active Comparator: Moxifloxacin<br>400mg tablet will be administrated once a week. | Drug: Moxifloxacin<br>* 400mg tablet will be administrated once a week.<br>|
| Placebo Comparator: Placebo<br>Placebo will be intravenously administered once a week. | Drug: Placebos<br>* Placebo will be intravenously administered once a week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 1h, 1.5h, 2h, 3h, 4h, 6h, 12h, 24h after dosing |