Last reviewed · How we verify
A Double-Blind Study in Healthy Volunteers to Assess the Effect of E7080 on the QTc Interval
This is a double-blind (vis-a-vis lenvatinib), randomized, placebo-controlled, three-treatment, three-way crossover study in healthy subjects. There are two phases in this study: Pre-Randomization and Randomization. The Pre-Randomization Phase consists of Screening and Baseline Period 1. The Randomization Phase consists of five periods: Treatment Period 1, Baseline Period 2, Treatment Period 2, Baseline Period 3, and Treatment Period 3. Completion of study termination procedures will be performed at Visit 11.
Details
| Lead sponsor | Eisai Inc. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 52 |
| Start date | 2010-12 |
Conditions
- Refractory Solid Tumors
- Lymphomas
Interventions
- Lenvatinib
- Moxifloxacin 400 mg
- Placebos (matched to 4 mg and 10 mg lenvatinib capsules).
Primary outcomes
- To evaluate the potential for QT/QTc prolongation by 32 mg lenvatinib using a placebo control and moxifloxacin as the positive control. — 2 months
Countries
United States