Phase I Study of OPC-61815

Phase 1

Completed

• Conditions: Congestive Heart Failure
• Interventions: Drug: OPC-61815 32mg; Drug: OPC-61815 16mg; Drug: Placebos; Drug: Moxifloxacin

• Registration Number: NCT03510663
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-18
• Study First Submitted QC: 2018-04-26
• Study First Posted: 2018-04-27
• Study Start: 2018-05-08
• Primary Completion: 2018-07-05
• Study Completion: 2018-07-05
• Results First Submitted: 2021-03-12
• Status Verified: 2021-04
• Results First Submitted QC: 2021-04-13
• Last Update Submitted: 2021-04-13
• Results First Posted: 2021-05-10
• Last Update Posted: 2021-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
OPC-61815 32mg	OPC-61815 32mg	OPC-61815 32mg will be intravenously administered once a week.
OPC-61815 16mg	OPC-61815 16mg	OPC-61815 16mg will be intravenously administered once a week.
Placebo	Placebos	Placebo will be intravenously administered once a week.
Moxifloxacin	Moxifloxacin	400mg tablet will be administrated once a week.

Primary Outcome Measures

Name	Time	Method
Time-matched Difference Between the OPC-61815/Moxifloxacin and Placebo Data in Change From Baseline for QTcF in 12-lead Holter Electrocardiogram (ECG)	Baseline, 1h, 1.5h, 2h, 3h, 4h, 6h, 12h, 24h after dosing	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.

Trial Locations

Locations (1)

Kyusyu Region; 🇯🇵 Fukuoka, Japan