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Phase I Study of OPC-61815

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03510663
Recruitment Status : Completed
First Posted : April 27, 2018
Results First Posted : May 10, 2021
Last Update Posted : May 10, 2021
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Study Description
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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

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Drug: OPC-61815 16mg Drug: OPC-61815 32mg Drug: Moxifloxacin Drug: Placebos Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : May 8, 2018
Actual Primary Completion Date : July 5, 2018
Actual Study Completion Date : July 5, 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: OPC-61815 16mg
OPC-61815 16mg will be intravenously administered once a week.
 Drug: OPC-61815 16mg
OPC-61815 16mg will be intravenously administered once a week.
Experimental: OPC-61815 32mg
OPC-61815 32mg will be intravenously administered once a week.
 Drug: OPC-61815 32mg
OPC-61815 32mg will be intravenously administered once a week.
Active Comparator: Moxifloxacin
400mg tablet will be administrated once a week.
 Drug: Moxifloxacin
400mg tablet will be administrated once a week.
Placebo Comparator: Placebo
Placebo will be intravenously administered once a week.
 Drug: Placebos
Placebo will be intravenously administered once a week.


Outcome Measures
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Primary Outcome Measures :
  1. Time-matched Difference Between the OPC-61815/Moxifloxacin and Placebo Data in Change From Baseline for QTcF in 12-lead Holter Electrocardiogram (ECG) [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03510663


Locations
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Japan
Kyusyu Region
Fukuoka, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
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Study Director: Osamu Sato Otsuka Pharmaceutical Co., Ltd.
  Study Documents (Full-Text)

Documents provided by Otsuka Pharmaceutical Co., Ltd.:
Study Protocol  [PDF] February 27, 2018
Statistical Analysis Plan  [PDF] September 25, 2018

More Information
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Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03510663    
Other Study ID Numbers: 263-102-00005
JapicCTI-183934 ( Other Identifier: Japic )
First Posted: April 27, 2018    Key Record Dates
Results First Posted: May 10, 2021
Last Update Posted: May 10, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Moxifloxacin
Anti-Bacterial Agents
Anti-Infective Agents
 Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents