Trials / Completed
CompletedNCT03475459
Investigation of Arrhythmogenic Effect of NPC-15 (NPC-15-7)
A Clinical Pharmacology Study of NPC-15 to Evaluate Arrhythmogenic Effect in Healthy Adults
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Nobelpharma · Industry
- Sex
- All
- Age
- 20 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
A study to assess the QTc prolongation effect of NPC-15 (melatonin 8mg or 16mg)
Detailed description
This study is a single center, open label, dose escalation trial to evaluate prolongation effect on QT interval of NPC-15 (melatonin 8mg or 16mg). The trial compose of 3 periods; During the each period, eligible volunteers wll be administered placebo, NPC-15 4g (melatonin 8mg) and NPC-15 8g(melatonin 16mg) as a sequential manner.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NPC-15 and/or Placebo | The dosage and regimen of the study drug in each period is the following. Period I : NPC-15 placebo granules 8 g Period II : NPC-15 placebo granules 4 g + NPC-15 granules 0.2% 4 g (melatonin 8 mg) Period III : NPC-15 granules 0.2% 8 g (melatonin 16 mg) |
Timeline
- Start date
- 2018-04-03
- Primary completion
- 2018-04-29
- Completion
- 2018-04-29
- First posted
- 2018-03-23
- Last updated
- 2018-06-28
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT03475459. Inclusion in this directory is not an endorsement.