Overview

Cardiac Safety Evaluation of P03277

Status:
Completed
Trial end date:
2018-06-07
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Guerbet
Treatments:
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination