drugset / Trial / NCT03657264

Cardiac Safety Evaluation of P03277

NCT03657264

Phase 1 Completed 48 enrolled Guerbet
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

EvaluationDrugModalityDoseRoute
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.