NCT03657264

Cardiac Safety Evaluation of P03277

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Guerbet · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

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.

Detailed description

Each subjects will be administered with 4 products (P03277 at the 2 different doses, placebo and moxifloxacin) in a 4\*4 cross over sequence balanced for first order carry over effect. Twelve subjects will be assigned to each sequence (6 males and 6 females). The volunteers will be enrolled sequentially by cohort of 8 subjects. ECG measurements will be compared with ECG parameters collected after administration of placebo (Nacl 0.9%). The test sensitivity will be assessed using a positive control (moxifloxacin 400 mg per os) known to induce delays in QT intervals.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-08-21
• Primary completion: 2018-06-07
• Completion: 2018-06-07
• First posted: 2018-09-05
• Last updated: 2022-07-18
• Results posted: 2019-08-22

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study