At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 48 enrolled
Drug / intervention
OPC-61815 16mg +3 moredrug
Likely dose
OPC-61815 16mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating OPC-61815 16mg, OPC-61815 32mg, and 2 other interventions for Congestive Heart Failure. Completed, enrolled 48 participants across 1 site.
Detailed Summary
To investigate the effects of intravenous administration of OPC-61815 at 16 and 32 mg on QT/QTc interval in healthy male subjects
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongestive Heart Failure
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
First PostedApr 2018
Enrollment StartMay 2018
Primary CompletionJul 2018
TodayJul 2026
First PostedApr 27, 2018
Enrollment StartMay 8, 2018
Primary CompletionJul 5, 2018
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 8.2 years ago
Interventions
OPC-61815 16mgdrug
OPC-61815 16mg will be intravenously administered once a week.
OPC-61815 32mgdrug
OPC-61815 32mg will be intravenously administered once a week.
Moxifloxacindrug
400mg tablet will be administrated once a week.
Placebosdrug
Placebo will be intravenously administered once a week.