MedTrace Logo

Phase I Study of OPC-61815

NCT03510663 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2021-05-10

Study results available
· View outcomes & findings →

Summary

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

Conditions

  • Congestive Heart Failure

Interventions

DRUG

OPC-61815 16mg

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

DRUG

OPC-61815 32mg

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

DRUG

Moxifloxacin

400mg tablet will be administrated once a week.

DRUG

Placebos

Placebo will be intravenously administered once a week.

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Osamu Sato · Otsuka Pharmaceutical Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-08
Primary Completion
2018-07-05
Completion
2018-07-05

Countries

  • Japan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03510663 on ClinicalTrials.gov