Phase 1 N=48 Randomized Triple-blind Treatment

Phase I Study of OPC-61815

Congestive Heart Failure

Bottom Line

View on ClinicalTrials.gov: NCT03510663 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2021

Primary outcome: Primary: Time-matched Difference Between the OPC-61815/Moxifloxacin and Placebo Data in Change From Baseline for QTcF in 12-lead Holter Electrocardiogram (ECG) — 0.9; 0.0; 9.9; -0.9 msec

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: OPC-61815 16mg (Drug); OPC-61815 32mg (Drug); Moxifloxacin (Drug); Placebos (Drug)
Age: Adult · 20+ yrs
Sex: Male
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Primary completion: Jul 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Time-matched Difference Between the OPC-61815/Moxifloxacin and Placebo Data in Change From Baseline for QTcF in 12-lead Holter Electrocardiogram (ECG)	0.9; 0.0; 9.9; -0.9; 2.0; 1.3	—

Summary

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

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

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Data sourced from ClinicalTrials.gov (NCT03510663). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.