Phase I Study of OPC-61815

Otsuka Pharmaceutical Co., Ltd.48 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Congestive Heart Failure

Interventions

OPC-61815 16mgDRUG

OPC-61815 16mg will be intravenously administered once a week.

OPC-61815 32mgDRUG

OPC-61815 32mg will be intravenously administered once a week.

MoxifloxacinDRUG

400mg tablet will be administrated once a week.

Eligibility

Sex: MALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Kyusyu Region

Fukuoka, Japan

Outcomes

Primary Outcomes

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.

Time frame: Baseline, 1h, 1.5h, 2h, 3h, 4h, 6h, 12h, 24h after dosing

Data from ClinicalTrials.gov

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