Phase1 study of OPC-61815
- Conditions
- Congestive heart failure
- Registration Number
- JPRN-jRCT2080223877
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
There was no QTcF prolongation after dosing with OPC-61815. No deaths, other serious TEAEs, and TEAEs leading to discontinuation of the IMP occurred in this trial. Furthermore, no TEAEs relating to ECG findings were reported for any subject. The above results demonstrated 1-hour intravenous administration of OPC-61815 at 16 and 32 mg were well tolerated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Male
- Target Recruitment
- 48
1) 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
2) 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
1) 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
2) Subjects with a serum electrolyte abnormality (hypokalemia, hypomagnesemia, hypocalcemia, etc)
3) Subjects with a family history of sudden death
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pharmacodynamics<br>QTcF difference between the OPC-61815 and placebo
- Secondary Outcome Measures
Name Time Method pharmacodynamics<br>12-Lead Holter ECG parameters and ECG waveform patterns