At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 48 enrolled

Drug / intervention

P03277 0.1 mmol/kg +3 moredrug

Likely dose

Moxifloxacin 400mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03657264

NCT03657264Phase 1Completed

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Thorough QT/QTc Study to Assess the Electrocardiographic Safety of a New Gadolinium-based Contrast Agent P03277 in Healthy Volunteers

Guerbet·interventional·Posted Sep 5, 2018·Updated Jul 18, 2022

In Brief

A Phase 1 clinical trial evaluating P03277 0.1 mmol/kg, Moxifloxacin 400mg, and 2 other interventions for Healthy Volunteers. Completed, enrolled 48 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHealthy Volunteers

CountriesBelgium

Collaborators--

Timeline

Phase 1CompletedFinished

201820192020202120222023202420252026

Enrollment StartAug 2017

Primary CompletionJun 2018

First PostedSep 2018

TodayJul 2026

First PostedSep 5, 2018

Enrollment StartAug 21, 2017

Primary CompletionJun 7, 2018

TodayJul 2, 2026

Enrollment to primary: 10 monthsPosted 7.8 years ago

Interventions

P03277 0.1 mmol/kgdrug

Single intravenous bolus injection at 2 mL/sec

Moxifloxacin 400mgdrug

One tablet per os

NaCl 0.9%drug

Single intravenous bolus injection at 2 mL/sec

P03277 0.3 mmol/kgdrug

Single intravenous bolus injection at 2 mL/sec