Phase I Study of OPC-61815

Otsuka

Status and phase: Completed; Phase 1

Conditions: Congestive Heart Failure

Treatments: Drug: Moxifloxacin; Drug: OPC-61815 16mg; Drug: OPC-61815 32mg; Drug: Placebos

Study type: Interventional

Funder types: Industry

Identifiers

NCT03510663

263-102-00005

JapicCTI-183934 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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48 participants in 4 patient groups, including a placebo group

OPC-61815 16mg

Experimental group

Description:

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

Treatment:

Drug: OPC-61815 16mg

OPC-61815 32mg

Experimental group

Description:

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

Treatment:

Drug: OPC-61815 32mg

Moxifloxacin

Active Comparator group

Description:

400mg tablet will be administrated once a week.

Treatment:

Drug: Moxifloxacin

Placebo

Placebo Comparator group

Description:

Placebo will be intravenously administered once a week.

Treatment:

Drug: Placebos