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Cardiac Safety Evaluation of P03277

NCT03657264 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2022-07-18

Study results available
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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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

P03277 0.1 mmol/kg

Single intravenous bolus injection at 2 mL/sec

DRUG

Moxifloxacin 400mg

One tablet per os

DRUG

NaCl 0.9%

Single intravenous bolus injection at 2 mL/sec

DRUG

P03277 0.3 mmol/kg

Single intravenous bolus injection at 2 mL/sec

Sponsors & Collaborators

  • Guerbet

    lead INDUSTRY

Principal Investigators

  • Frederic Vanhoutte, MD · SGS Clinical Pharmacology Unit

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-21
Primary Completion
2018-06-07
Completion
2018-06-07
FDA Drug
Yes

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03657264 on ClinicalTrials.gov