Trials / Completed
CompletedNCT03510663
Phase I Study of OPC-61815
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Otsuka Pharmaceutical Co., Ltd. · Industry
- Sex
- Male
- Age
- 20 Years – 45 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-05-08
- Primary completion
- 2018-07-05
- Completion
- 2018-07-05
- First posted
- 2018-04-27
- Last updated
- 2021-05-10
- Results posted
- 2021-05-10
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT03510663. Inclusion in this directory is not an endorsement.