drugset / Trial / NCT03657264
Cardiac Safety Evaluation of P03277
RandomizedCrossoverTriple-blindDiagnostic
Summary
The study is a Phase I, Single center, Randomized, Cross-over Double-blind Placebo-controlled and Open-label Positive-controlled (moxifloxacin) in healthy volunteers. The primary objective is to assess the cardiac safety after administration of P03277 to 48 healthy volunteers at dose of 0.1 mmol/kg (anticipated clinical dose) and 0.3 mmol/kg (supra-clinical dose) by evaluating the QT and QTc intervals.
Timeline
- Start
- 2017-08-21
- Primary completion
- 2018-06-07
- Completion
- 2018-06-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gadopiclenol | Diagnostic / imaging agent | 0.1 mmol | Intravenous |
| Subject | Gadopiclenol | Diagnostic / imaging agent | 0.3 mmol | Intravenous |
| Subject | Moxifloxacin | Small molecule | 400 mg | Oral |
Indications
No indication recorded.